FDA Approves Decnupaz (pivekimab sunirine-pvzy), the First ADC for Adults With BPDCN

oncodaily - On May 27, 2026, the U.S. FDA granted approval to pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for the treatment of adults with blastic plasmacytoid […]

AI Summary: The FDA approved pivekimab sunirine (Decnupaz/pvzy), the first antibody‑drug conjugate for blastic plasmacytoid dendritic cell neoplasm (BPDCN), marking a regulatory win for an ultra‑rare blood cancer. The decision underscores ADCs’ growing role in niche hematologic malignancies and anchors AbbVie’s expanding ADC strategy.

#pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

Paolo Tarantino: Packed Educational Session on Novel ADCs

17 hrs / oncodaily

Kelly Shanahan: Interesting ASCO 2026 Discussion on ADC Ocular Side Effects

39 hrs / oncodaily

KEYNOTE-905 at ASCO 2026: HRQoL With Perioperative EV/Pembrolizumab in Cisplatin-Ineligible MIBC

40 hrs / oncodaily

FDA Approves Decnupaz (pivekimab sunirine-pvzy), the First ADC for Adults With BPDCN

3 days / oncodaily

FDA Approved Pivekimab Sunirine‑Pvzy for Adult Patients – BPDCN International Registry

3 days / oncodaily

AbbVie’s ADC Strategy Notches Another Win With FDA Approval in Ultra-Rare Blood Cancer

3 days / medcitynews / Frank Vinluan

FDA grants Daiichi Sankyo and AstraZeneca’s Datroway a key breast cancer approval

Lei Lei Wu / endpoints - The FDA has approved the TROP2-directed antibody-drug conjugate Datroway as a first-line option for triple-negative breast cancer, giving Daiichi Sankyo and AstraZeneca a leg up over their competitor Gilead. The approval marks Datroway’s third, after ...

AI Summary: Daiichi Sankyo and AstraZeneca’s breast cancer therapy Datroway has cleared key regulatory hurdles, winning FDA approval and earning backing from European regulators. The approvals validate pivotal trial results and pave the way for clinical adoption in the indicated patient population, prompting clinicians to prepare for integration into treatment pathways and health systems to weigh formulary and access decisions.

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda #oncology #healthcarefinance #cancerresearch #clinicaltrials

Clinicians weigh Datroway’s role in TNBC care (3)
FDA win and market stakes for Datroway (3)
All Other Stories

9 days / bbc

Eli Lilly’s Triple Combo Obesity Drug Tops 28% Weight Loss in a Pivotal Trial

Frank Vinluan / medcitynews - Eli Lilly’s retatrutide set a high mark in weight loss for obesity drugs, but with clinical trial results that show some new side effects. More detailed data from the Phase 3 study are scheduled for presentation next month during the American Diabetes Ass…

AI Summary: Eli Lilly’s triple‑agonist produced average weight loss exceeding 28% in a pivotal study, positioning the drug as a leader among late‑stage obesity candidates. The results close the gap with surgical outcomes and promise major clinical and commercial impact—assuming regulators are satisfied and long‑term safety and durability data hold up.

#obesity #pharmaceuticals #elililly #weightloss #biotech #drugdevelopment #fda #clinicaltrials

GLP-1 drugs closing gap with bariatric surgery (3)
GLP-1 mechanisms and potential cancer benefits (3)
Lilly’s retatrutide trial: 28% weight loss and implications (4)
All Other Stories

GLP-1 drugs closing gap with bariatric surgery

Weight loss drug semaglutide helps patients who do not respond to bariatric surgery, research finds

9 days / medicalxpress

Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial

10 days / nature / Chloe Stanley

GLP-1s are closing the gap with bariatric surgery. Here’s what the research shows.

10 days / beckershospitalreview / Ella Jeffries

GLP-1 mechanisms and potential cancer benefits

GLP-1s and cancer outcomes: What new research shows

9 days / beckershospitalreview / Elizabeth Gregerson

Ozempic and other GLP-1 RAs could slow progression of some cancers, data suggest

9 days / medicalxpress

Researchers identify avenue for enhanced GLP-1-induced weight loss

9 days / medicalxpress

Lilly’s retatrutide trial: 28% weight loss and implications

Inside Makary’s ouster; Another win for Lilly’s triple-G; and more

8 days / endpoints / Max Gelman

Eli Lilly’s Triple Combo Obesity Drug Tops 28% Weight Loss in a Pivotal Trial

10 days / medcitynews / Frank Vinluan

Lilly’s triple agonist still leads among late-stage obesity assets

10 days / endpoints / Elizabeth Cairns

Experimental Drug Yields Dramatic Weight Loss

10 days / nytimes / Gina Kolata and Rebecca Robbins

All Other Stories

Telehealth is Making GLP-1s More Accessible – But Access Alone isn’t Enough

16 hrs / medcitynews / Ro Huntriss

ASCO 2026: updates on weight loss drugs and cancer

2 days / cancerresearchuk / Tim Gunn

CVS obesity drug deal puts Lilly on equal footing with Novo

3 days / healthcaredive / Kristin Jensen

Tirzepatide superior to intensified conventional care for early type 2 diabetes

4 days / medicalxpress

Low-insulinemic, planetary health diets optimize weight management during menopause

4 days / medicalxpress

EU regulator approves pill form of Novo Nordisk's Wegovy weight loss drug

9 days / medicalxpress

FDA Approves AstraZeneca Drug With New Approach to Lowering High Blood Pressure

Frank Vinluan / medcitynews - AstraZeneca’s Baxfendy is the first FDA-approved drug in a new class of medicines called aldosterone synthase inhibitors. The new mechanism of action is important for patients and for AstraZeneca, which has been looking for new drugs with blockbuster pote…

AI Summary: The FDA has approved a first-in-class oral agent that uses a novel mechanism to lower resistant hypertension, offering an alternative for patients who haven’t responded to standard therapies. The move expands treatment options and signals renewed industry focus on innovative vascular targets — finally something for stubborn blood pressure to complain about.

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda #clinicaltrials

Beetroot Juice May Help Lower Blood Pressure in Two Weeks for Older Adults, with Links to the Mouth’s Microbiome

2 days / discovermagazine

FDA approves 1st-in-class blood pressure drug

13 days / beckershospitalreview / Ella Jeffries

FDA Approves AstraZeneca Drug With New Approach to Lowering High Blood Pressure

13 days / medcitynews / Frank Vinluan

FDA approves AstraZeneca’s baxdrostat for certain patients with hypertension

13 days / endpoints / Elizabeth Cairns

FDA clears 1st AI sepsis monitoring tool

Giles Bruce / beckershospitalreview - A tool from tech company Bayesian Health has become the first continuous AI sepsis monitor to gain FDA approval. The solution monitors hospital patients to detect deterioration and flag sepsis early on. The application was developed at Baltimore-based Joh…

AI Summary: Regulators have cleared the first AI‑driven sepsis early‑warning system for clinical deployment, enabling hospitals to use algorithmic alerts to identify patients at risk of deterioration earlier. The clearance opens the door for broader adoption of AI in acute care while renewing debates about clinical oversight, false alarms and integration into existing workflows.

#healthcare #publichealth #fda #digitalhealth #medicaldevices #hospitaloperations #infectiousdisease #healthit #diagnostics

As AI identifies more at-risk patients, health systems face a capacity challenge

9 days / beckershospitalreview / Giles Bruce

Which AI companies health systems are betting on

10 days / beckershospitalreview / Naomi Diaz

OpenEvidence launches hands-free voice AI feature, expands hospital footprint with Cedars-Sinai tie-up

10 days / fiercehealthcare

Unintended consequences of legacy oversight in digital medicine

12 days / nature / Jochen K. Lennerz

A workflow utilizing general-purpose large language models for efficient structuring and data mining of bone scintigraphy narratives

15 days / nature

FDA approves early warning system for sepsis

19 days / medicalxpress

FDA clears 1st AI sepsis monitoring tool

19 days / beckershospitalreview / Giles Bruce

BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta

Ayisha Sharma / endpoints - BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in a rare but aggressive form of blood cancer, where AbbVie and Genentech’s Venclexta is used off-label. The FDA greenlit ...

AI Summary: BeOne Medicines secured FDA approval for a next-generation BCL2 inhibitor, positioning the drug as a direct challenge to AbbVie/Roche’s Venclexta franchise. The move reshuffles competitive dynamics in hematology, potentially offering clinicians an alternative and setting the stage for market share battles and payer negotiations. Expect aggressive positioning and head-to-head data requests.

#pharmaceuticals #drugpricing #biotech #drugdevelopment #fda #oncology #healthcarefinance #cancerresearch #clinicaltrials

FDA Approval Gives BeOne Medicines a New Challenger to AbbVie, Roche Cancer Drug

17 days / medcitynews / Frank Vinluan

BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta

17 days / endpoints / Ayisha Sharma

Positive VOLGA Phase III Results for Imfinzi Plus Neoadjuvant EV in MIBC

oncodaily - On May 14, 2026, AstraZeneca announced positive high-level results from a planned interim analysis of the Phase III VOLGA trial, evaluating perioperative Imfinzi with or without Imjudo in combination with […]

AI Summary: Phase III VOLGA trial results reveal that combining durvalumab (Imfinzi) with neoadjuvant enfortumab vedotin improved survival outcomes in muscle‑invasive bladder cancer. Investigators and industry voices highlight potential practice-changing implications for perioperative therapy, while stakeholders weigh regulatory filings and integration into treatment guidelines. Clinicians will want full datasets and toxicity details.

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

Clinician reactions, biology and resistance concerns (4)
Global GU oncology meetings and community coverage (3)
VOLGA Phase III readout and regulatory landscape (3)
All Other Stories

Clinician reactions, biology and resistance concerns

Understanding treatment response in high-risk bladder cancer

13 days / medicalxpress

Laura Bukavina: Targeting Tumor Biology and EV Resistance in Urothelial Cancer Treatment

14 days / oncodaily

Katy Beckermann: Phase III VOLGA Shows EFS and OS Benefit in Cisplatin-Ineligible MIBC

15 days / oncodaily

Tom Powles: VOLGA Trial Shows Survival Improvements of EV and Durvalumab in Bladder Cancer

17 days / oncodaily

Global GU oncology meetings and community coverage

Highlights From How I Treat Bladder Cancer in 2026 Global Virtual Summit

11 days / oncodaily

10 Must-Read Posts In GU Oncology This Week

13 days / oncodaily

The Global Impact of URO-ONCO 2026

15 days / oncodaily

VOLGA Phase III readout and regulatory landscape

FDA approved Atezolizumab for adjuvant treatment of MDR–positive MIBC

15 days / oncodaily

Positive VOLGA Phase III Results for Imfinzi Plus Neoadjuvant EV in MIBC

16 days / oncodaily

AstraZeneca follows Merck with Phase 3 win in bladder cancer

17 days / endpoints / Elizabeth Cairns

All Other Stories

Adjuvant Radiotherapy After Radical Cystectomy in High-Risk Muscle-Invasive Bladder Cancer

8 days / oncodaily

David Aggen: What Are the Next Steps After Progression on EV-Based Therapy?

9 days / oncodaily

Priyamvada Maitre: BART Trial Shows Benefits of Adjuvant Radiotherapy in High-Risk Bladder Cancer

9 days / oncodaily

Yasmine Hassan: Patient Perspectives on Shared Decision-Making in MIBC

9 days / oncodaily

Implantable tech could cast new light on bladder cancer treatment

10 days / medicalxpress

Laura Bukavina: Presenters Showcase New Bladder Cancer Research at AUA26

10 days / oncodaily

Sergey Badalyan: Welcoming Global Experts for How I Treat Bladder Cancer in 2026 Webinar

10 days / oncodaily

ctDNA Testing After Neoadjuvant Chemotherapy and Radical Cystectomy Predicts Recurrence Risk in Patients with MIBC

10 days / esmo

FDA Approves Signatera CDx as Companion Diagnostic for ctDNA-Guided Adjuvant Atezolizumab in MIBCr

11 days / oncodaily

Around 610,000 People Are Diagnosed with Bladder Cancer Every Year – Kenyan Network of Cancer Organizations

14 days / oncodaily

Supreme Court preserves access to abortion pill by mail

Sydney Halleman / healthcaredive - The ruling maintains access to mifepristone while litigation continues. The drug can still be prescribed at pharmacies or by mail without requiring in-person visits.

AI Summary: The Supreme Court intervened to maintain access to mifepristone, temporarily restoring telehealth prescribing and preserving mail distribution while litigation proceeds. The decision keeps the pill available nationwide, blocking lower-court restrictions that would have sharply limited remote access and complicated routine clinical care for patients and providers.

#healthcare #pharmaceuticals #publichealth #governmentpolicy #fda #digitalhealth #reproductivehealth #telemedicine

Religious Anti-Abortion Center Finds Opportunity in Town Without OB-GYNs

11 days / kffhealthnews / Jazmin Orozco Rodriguez

Expert explains the science, safety, and legal landscape around mifepristone used in abortions, miscarriage care

13 days / medicalxpress

Supreme Court allows mail-ordered mifepristone

16 days / beckershospitalreview / Paige Twenter

SCOTUS temporarily restores telehealth access to abortion pill mifepristone

16 days / fiercehealthcare

Supreme Court preserves access to abortion pill by mail

16 days / healthcaredive / Sydney Halleman

Supreme Court preserves mail access for abortion pill

16 days / endpoints / Nicole DeFeudis

Supreme Court Allows Abortion Pill Access by Mail to Continue

17 days / nytimes / Ann E. Marimow

F.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure

Christina Jewett / nytimes - The agency’s top food official will step in as acting commissioner, after Dr. Makary’s tumultuous run as the nation’s top food, drug, tobacco and medical device regulator.

AI Summary: F.D.A. commissioner Marty Makary resigned after weeks of intense scrutiny and internal pressure over leadership and policy choices, following reports he faced possible removal. The agency now confronts leadership turbulence as officials rush to steady regulatory priorities, reassure stakeholders and clean up an exit that leaves unfinished reviews and awkward staff memos.

#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda

Firing reports and buildup to Makary's ouster (4)
Regulatory ripple effects and agency departures (3)
Resignation announced and immediate leadership vacuum (5)
All Other Stories

Firing reports and buildup to Makary's ouster

Post-Hoc: Why FDA Commissioner Marty Makary was ousted

18 days / endpoints / Drew Armstrong

FDA Commissioner Makary to resign, source says

19 days / endpoints / Max Bayer

Makary’s leadership in question at FDA: 5 things to know

20 days / beckershospitalreview / Kristin Kuchno

FDA Commissioner Makary to be fired, WSJ reports

23 days / endpoints / Drew Armstrong

Regulatory ripple effects and agency departures

CDER chief Høeg expected to leave FDA, according to source

16 days / endpoints / Max Bayer

Under FDA Clinical Hold, Aardvark Therapeutics Seeks Path Forward for Metabolic Drug

16 days / medcitynews / Frank Vinluan

FDA Blocked Melanoma Drug as Confusion Reigned Under Makary

16 days / kffhealthnews / Arthur Allen

Resignation announced and immediate leadership vacuum

Post-Hoc Live: Makary's out at FDA and what comes next

16 days / endpoints / Drew Armstrong

FDA commissioner is out: 8 things to know

19 days / beckershospitalreview / Kristin Kuchno

FDA Commissioner Marty Makary to resign, capping turbulent tenure: report

19 days / fiercehealthcare

FDA chief Marty Makary resigns from agency, ending tumultuous tenure

19 days / healthcaredive / Ben Fidler

F.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure

19 days / nytimes / Christina Jewett

All Other Stories

FDA blocked melanoma drug as confusion reigned under Makary

13 days / medicalxpress

Flavored vapes led to a major shake‑up at the FDA

13 days / medicalxpress

After FDA commissioner departure, drug center head is out

13 days / beckershospitalreview / Kelly Gooch

Houman David Hemmati: The FDA Commissioner Role is Open – Pivotal Moment for US Medicine

14 days / oncodaily

FDA official who scrutinized COVID shots and antidepressants is out in latest shake-up

15 days / medicalxpress

Makary resigns; Biogen reports Alzheimer’s data; and more

15 days / endpoints / Nicole DeFeudis

Blog Post

FDA Commissioner Marty Makary has resigned after weeks of intense scrutiny and internal pressure, multiple outlets reported. The resignation follows reports that President Trump had approved a plan to oust Makary — a report the White House publicly downplayed — and contemporaneous reporting that Makary was preparing to step down. Makary was confirmed as FDA commissioner in March 2025. The New York Times said the agency’s top food official will serve as acting commissioner. Observers describe Makary’s tenure as tumultuous, marked by leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. Agency officials are scrambling to steady regulatory priorities, reassure stakeholders and manage an exit that leaves unfinished reviews and awkward staff memos.

A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

Frank Vinluan / medcitynews - Partner Therapeutics’ Bizengri is now FDA approved for treating advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. Partner acquired U.S. rights to this bispecific antibody from Merus in 2024. The post A Cancer Driven by Ultra-Rare Mutation …

AI Summary: The FDA approved zenocutuzumab‑zbco for NRG1‑fusion–positive cholangiocarcinoma, delivering the first cleared therapy for cancers driven by this ultra‑rare genomic alteration. Trial data showed meaningful responses in heavily pretreated patients, prompting regulators to greenlight a precision option that offers targeted benefit where none existed — a small‑population win for genomic oncology.

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials #genetics

Ahmet Dirican: Durable Response in IDH2-Mutant Cholangiocarcinoma With Venetoclax and Decitabine

16 days / oncodaily

Juan W. Valle: Registration Opens for ILCA Annual Conference in Brussels

19 days / oncodaily

FDA green lights Bizengri drug to treat rare, aggressive bile duct cancer

20 days / medicalxpress

A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

20 days / medcitynews / Frank Vinluan

Rare bile duct cancer drug earns FDA approval

20 days / beckershospitalreview / Ella Jeffries

FDA Approved Zenocutuzumab-zbco for Advanced NRG1 Fusion-Positive Cholangiocarcinoma

22 days / oncodaily

With Commissioner Under Pressure, F.D.A. Opens Door to Flavored Vapes

Christina Jewett / nytimes - Though illicit e-cigarettes have flooded in from China, the new policy could allow major tobacco companies to sell from prime shelf space at thousands of stores.

AI Summary: Facing mounting pressure, the FDA has signaled authorization of fruit‑flavored vaping products for adults, a regulatory shift framed as adult access and harm reduction. Public‑health experts warn the move risks increasing youth appeal and reignites debate over flavors, enforcement, and whether potential population‑level tradeoffs were adequately considered.

#healthcare #publichealth #governmentpolicy #fda #behavioralhealth #healthdisparities #adolescenthealth

Prisca Githuka: Flavours Play a Huge Role in Reducing Caution Around Nicotine Products

14 days / oncodaily

'Engineered for addiction': WHO slams soaring nicotine pouch sales

16 days / medicalxpress

Top Kennedy Spokesman Resigns in Protest Over New Vaping Policy

18 days / nytimes / Sheryl Gay Stolberg

New statement identifies critical gaps in the science guiding e-cigarette regulation

20 days / medicalxpress

With Commissioner Under Pressure, F.D.A. Opens Door to Flavored Vapes

21 days / nytimes / Christina Jewett

FDA authorizes fruit-flavored vapes for adults

25 days / medicalxpress

The peptide problem: Hype is outrunning the evidence

medicalxpress - Health Canada recently warned Canadians not to buy or inject unauthorized peptide drugs sold online, naming products that include BPC-157, CJC-1295, ipamorelin, TB-500 and retatrutide.

AI Summary: The booming market for peptide therapies and supplements is racing past the science. Researchers report limited clinical evidence, unclear long-term safety, and weak regulatory oversight, while consumer demand and marketing hype surge. Clinicians urge caution: biological plausibility isn’t the same as proven benefit, and enthusiasm should not substitute for rigorous trials.

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda #researchfunding #clinicaltrials #supplements

Concern 'dangerous' performance enhancers are being sold online

20 days / bbc

The peptide problem: Hype is outrunning the evidence

25 days / medicalxpress

The peptide problem: Hype is outrunning the evidence

25 days / theconversation / Stuart Phillips, Professor, Kinesiology, Tier 1 Canada Research Chair in Skeletal Muscle Health, McM

Atara, Pierre Fabre's cell therapy to get another shot at FDA approval

Max Gelman / endpoints - There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said ...

AI Summary: Regulators have agreed to re-examine a previously rejected cell‑therapy application for a rare lymphoma, giving the Atara‑Pierre Fabre program another opportunity at approval. The decision follows additional data and stakeholder engagement, offering the developer a second bite at the apple and patients a renewed, if cautious, hope for a novel treatment pathway.

#pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

Top Early-Phase Hematologic Oncology Trials to Watch at EHA 2026

16 days / oncodaily

Top 10 Phase II/III Hematologic Oncology Trials to Watch at EHA 2026

16 days / oncodaily

Yan Leyfman: Off-the-Shelf CAR T for Faster Lymphoma Treatment

18 days / oncodaily

Tessera reveals strongest data yet for in vivo sickle cell therapy

18 days / endpoints / Ryan Cross

FDA to reconsider rare lymphoma treatment after rejection

23 days / beckershospitalreview / Ella Jeffries

Atara, Pierre Fabre's cell therapy to get another shot at FDA approval

24 days / endpoints / Max Gelman

FDA approves blood test to guide breast cancer therapy

Ella Jeffries / beckershospitalreview - The FDA has approved a companion diagnostic from Guardant Health to identify patients eligible for treatment with a targeted therapy developed by Pfizer and Arvinas. The blood-based test detects ESR1 mutations in patients with estrogen receptor-positive, …

AI Summary: The FDA approved a blood‑based test to help guide breast cancer treatment selection, authorizing a diagnostic that identifies patients more likely to benefit from specific therapies. The move could reduce unnecessary treatments and sharpen precision oncology, though broad clinical adoption will depend on further validation, payer coverage and clinician trust.

#healthcare #biotech #fda #medicaldevices #oncology #cancerresearch #diagnostics

ESMO Breast highlights and expert commentary (4)
FDA clearances reshape diagnostics and therapies (3)
Liquid biopsy, mutations and treatment resistance (4)
All Other Stories

ESMO Breast highlights and expert commentary

Amy Patel: Radiologists Can Make an Immense Difference for Patients at the State and Federal Level

20 days / oncodaily

Neil Vasan Congratulates Lajos Pusztai on Giants of Cancer Award

21 days / oncodaily

20 Posts Not To Miss From ESMO Breast Cancer Congress 2026

21 days / oncodaily

Aruni Ghose: Ethnicity-Based Treatment Endpoints in mBC

21 days / oncodaily

FDA clearances reshape diagnostics and therapies

FDA clears ArteraAI Breast for breast cancer risk stratification

19 days / medicalxpress

Technology receives FDA approval for breast cancer treatment

23 days / medicalxpress

FDA approves blood test to guide breast cancer therapy

25 days / beckershospitalreview / Ella Jeffries

Liquid biopsy, mutations and treatment resistance

Germline BRCA2 mutations foster resistance to CDK4/6 inhibitors in breast cancer

20 days / nature

Katarzyna Pogoda: Our Study on Receptor Conversion in Residual Luminal Breast Cancer at ESMO BC26

21 days / oncodaily

Rishabh Jain: HER2CLIMB-02 Updated Results at ESMO Breast 2026

22 days / oncodaily

Waleed Arafat: Liquid Biopsy in Metastatic Breast Cancer at ASEER Woman Oncology Conference

22 days / oncodaily

All Other Stories

EXTEND Trial Links ctDNA Clearance to Improved Outcomes After Radiotherapy

15 days / oncodaily

Blood test that detects tumor DNA could help guide treatment when cancer has spread

15 days / medicalxpress

Karamvir Yadav: Bone Health Should Be Part of Every HR+ Breast Cancer Discussion

16 days / oncodaily

Why breast cancer becomes more deadly with age

16 days / medicalxpress

SABCS 2025 Highlights: Liquid Biopsy in Breast Cancer – ISLB

17 days / oncodaily

Nicholas Navin: Building a Classifier to Predict Chemotherapy Benefit in TNBC

17 days / oncodaily

Metastatic Breast Cancer: Liquid Biopsy Reveals an Immunovascular Signature

18 days / oncodaily

Karamvir Yadav: Liquid Biopsy Is Reshaping First-Line mCRPC Decision-Making

18 days / oncodaily

A 13-gene panel may help predict response to chemotherapy in triple-negative breast cancer

18 days / medicalxpress

Gianrico Farrugia: Simple Blood Test That Can Noninvasively Profile Tumor Microenvironments

18 days / oncodaily

FDA Approves Vepdegestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer

18 days / esmo

Molecular profile of residual triple-negative breast cancer: opportunities for post-neoadjuvant therapeutic interventions

19 days / nature

Amgen files update to Tavneos label as FDA escalates push to withdraw

Nicole DeFeudis / endpoints - Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...

AI Summary: Regulators have intensified scrutiny of Amgen’s Tavneos, weighing withdrawal amid safety and efficacy concerns. Amgen responded by filing a label update as the agency evaluates next steps, setting up a regulatory standoff that could alter patient access and the drug’s commercial fate while investigators review supporting trial data.

#healthcare #pharmaceuticals #governmentpolicy #biotech #drugdevelopment #fda #clinicaltrials

Amgen files update to Tavneos label as FDA escalates push to withdraw

4 wks / endpoints / Nicole DeFeudis

FDA weighs pulling Amgen drug

4 wks / beckershospitalreview / Ella Jeffries

Vivek Subbiah: F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer

oncodaily - Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared a post on LinkedIn: “Wow! It’s Big news on Friday. F.D.A. Grants Early Access to Promising Drug for […]

AI Summary: The FDA has authorized early access to a promising experimental therapy for pancreatic cancer, opening an expanded‑access pathway so eligible patients can receive the drug before full approval. Regulators based the decision on encouraging early clinical signals of activity and manageable safety data, aiming to offer options for a disease with few effective treatments—because pancreatic cancer isn’t known for its patience.

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda #oncology #pancreaticcancer #cancerresearch #clinicaltrials

Daraxonrasib expanded access: FDA opens early pathway (6)
Research advances: diagnostics and targeted therapies for pancreatic cancer (5)
All Other Stories

Daraxonrasib expanded access: FDA opens early pathway

FDA grants expanded access to the pancreatic cancer drug daraxonrasib

27 days / medicalxpress

Maen Abdelrahim: FDA Grants Expanded Access for Daraxonrasib in Pancreatic Cancer

27 days / oncodaily

Yannick Buccella: Historic Day for the GI Oncology Community

28 days / oncodaily

FDA Greenlit New Pancreatic Cancer Drug Daraxonrasib For Expanded Access

28 days / oncodaily

Vivek Subbiah: F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer

29 days / oncodaily

F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer

4 wks / nytimes / Rebecca Robbins and Gina Kolata

Research advances: diagnostics and targeted therapies for pancreatic cancer

Michael Chuong: 4-Year Success Using Ablative Radiation for Advanced Pancreatic Cancer

26 days / oncodaily

Anirban Maitra: Strong Showing from NYU Langone Health at the Pancreas Club Meeting in Chicago

26 days / oncodaily

Pancreatic ductal adenocarcinoma: integrating molecular insights for targeted interventions

27 days / nature

Blocking a cellular inflammation process could result in effective therapy for pancreatic cancer

28 days / medicalxpress

Microchip nanoparticle test spots pancreatic cancer in blood, outperforming biopsy in early trial

29 days / medicalxpress

All Other Stories

Phase 2 nITRO Trial: Perioperative NALIRIFOX in resectable PDAC

17 days / oncodaily

Daraxonrasib Shows Antitumour Activity Among Patients with Previously Treated RAS-mutated Pancreatic Ductal Adenocarcinoma

17 days / esmo

How an ‘Impossible’ Idea Led to a Pancreatic Cancer Breakthrough

19 days / nytimes / Gina Kolata and Rebecca Robbins

Dan Zhao: A New Article on Pancreatic Cancer

21 days / oncodaily

Daraxonrasib Shows Antitumor Activity in Previously Treated RAS-Mutated Pancreatic Cancer

22 days / oncodaily

Chadi Nabhan: Discussing Elraglusib Activity in Pancreatic Cancer With Deva Mahalingam

23 days / oncodaily

RAS(ON) inhibitor daraxonrasib shows promising results in advanced pancreatic cancer

24 days / medicalxpress

Pancreatic cancer drug extends survival 8.5 months: Study

24 days / beckershospitalreview / Elizabeth Gregerson

New AI model spots pancreatic cancer up to 3 years earlier than human doctors in test

24 days / livescience

Machine learning-based prognostic signature integrating mitochondrial function and programmed cell death patterns in pancreatic adenocarcinoma

25 days / nature

Ahmet Dirican: Pancreatic Cancer May Be Entering a New Era

25 days / oncodaily

Yan Leyfman: Redefining What’s Biologically Possible in Pancreatic Cancer

26 days / oncodaily

Pashtoon Kasi: FDA Expands Access to DaraxonRASib for Pancreatic Cancer

26 days / oncodaily

Yannick Neuder: Grenoble Alpes University Hospital Achieves a European First in the Fight Against Pancreatic Cancer

29 days / oncodaily

Court restricts abortion access across US by blocking mailing of mifepristone

abcnews - A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking the mailing of mifepristone

AI Summary: A federal appeals court has imposed new limits on distribution of mifepristone, blocking mail-order shipments and narrowing telehealth-based prescribing. The decision immediately complicates access for patients and clinicians who rely on remote care and pharmacy delivery, forcing last‑minute logistical changes, increased travel, and swift legal and policy responses as providers scramble to adapt.

#healthcare #pharmaceuticals #publichealth #governmentpolicy #fda #supplychain #ruralhealth #healthdisparities #reproductivehealth #telemedicine

Appeals court halts mail and telehealth access (4)
Clinical pivots and drug alternatives amid disruptions (3)
Supreme Court temporarily restores mail access (5)
All Other Stories

Appeals court halts mail and telehealth access

Federal appeals court blocks mailing of mifepristone

27 days / beckershospitalreview / Paige Twenter

A federal appeals court restricts access to abortion pills via telehealth

29 days / npr / Selena Simmons-Duffin

Federal Appeals Court Temporarily Halts Abortion Pill Access by Mail

4 wks / nytimes / Pam Belluck

Court restricts abortion access across US by blocking mailing of mifepristone

4 wks / abcnews

Clinical pivots and drug alternatives amid disruptions

How doctors and abortion advocates are pivoting as mifepristone access shifts

26 days / npr / Abby Wendle

Here's how medication abortion works with just one drug that's still fully available

27 days / npr / Mara Gordon

A federal court blocked a widely used abortion pill from distribution by mail. Here's what to know

29 days / abcnews

Supreme Court temporarily restores mail access

Supreme Court issues a stay, keeping the abortion pill mifepristone available by mail for now

26 days / medicalxpress

Supreme Court stays lower court’s decision on mail-ordered mifepristone

26 days / beckershospitalreview / Paige Twenter

SCOTUS temporarily restores online access to abortion pill after appeals court ruling

27 days / fiercehealthcare

Supreme Court Temporarily Restores Access to Abortion Pill by Mail

27 days / nytimes / Ann E. Marimow

Supreme Court restores mifepristone access by mail

27 days / endpoints / Max Bayer

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Supreme Court Continues Access to Abortion Pill by Mail, for a Few Days

20 days / nytimes / Ann E. Marimow

A critical legal deadline approaches for mailing abortion pills. What's next?

22 days / npr / Ryan Benk

Matthew Kurian: ODAC Votes 6–3 Against Camizestrant Approval In SERENA-6

oncodaily - Matthew Kurian, Assistant Professor of Medicine at the University of Kentucky College of Medicine and Physician at St. Elizabeth Healthcare, shared a post on LinkedIn: “Breaking: ODAC Votes 6-3 Against Camizestrant Approval […]

AI Summary: An FDA oncology advisory committee delivered a 6–3 vote against approval of camizestrant following review of the SERENA‑6 trial, flagging concerns about the data package and the drug’s claimed “new paradigm.” The panel’s negative recommendation raises serious regulatory and commercial uncertainty for AstraZeneca’s oral SERD program and its path forward.

#pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

Implications for HR+/HER2- treatment landscape (3)
ODAC rejects camizestrant approval (8)
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Implications for HR+/HER2- treatment landscape

Second-Line Treatment Options in Metastatic Breast Cancer After AI Plus CDK4/6 Inhibitor

28 days / oncodaily

Adrian Lee: ctDNA-Guided Switching in HR+/HER2− Breast Cancer and SERENA-6 Evidence

28 days / oncodaily

Vepdegestrant Improves PFS In ESR1-Mutant HR+ Metastatic Breast Cancer – Oncology Brothers

29 days / oncodaily

ODAC rejects camizestrant approval

Sarah Sammons: ODAC Votes and FDA Approval Decisions on Prescription Drugs

29 days / oncodaily

Amol Akhade: What are Key Concerned Raised by FDA Against SERENA-6 Trial

4 wks / oncodaily

Bishal Gyawali: Thoughts On SERENA-6 Trial In Light Of FDA ODAC Decision

4 wks / oncodaily

MinhTri Nguyen: Meaningful Negative Signal From The SERENA-6 ODAC Vote

4 wks / oncodaily

Matthew Kurian: ODAC Votes 6–3 Against Camizestrant Approval In SERENA-6

4 wks / oncodaily

FDA's oncology advisors vote against 'new paradigm' in AstraZeneca trial

4 wks / endpoints / Nicole DeFeudis

FDA, AstraZeneca prep for oncology adcomm

4 wks / endpoints / Max Bayer

AstraZeneca’s Camizestrant Faces FDA ODAC Review In ESR1-Mutated HR+/HER2− Breast Cancer

4 wks / oncodaily

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Olubukola Ayodele: PFS2 vs OS Debate in Metastatic Breast Cancer at ESMO Breast 2026

20 days / oncodaily

Tunch Akmandor: Discussing Emerging Directions in Translational Breast Cancer Research at ESMO Breast 2026

20 days / oncodaily

Olubukola Ayodele: Understanding MBC Endpoints – More Than Just a Number

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Ramy Sedhom: Premenopausal Hormone Receptor-Positive Pregnant Patients Could Be Safely Treated

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Amol Akhade: How to Make Sense of ESMO Breast 2026 Update

21 days / oncodaily

SERENA-6 Trial at ESMO Breast Cancer Congress 2026: Ongoing ctDNA Monitoring for ESR1 Mutations in Advanced Breast Cancer

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PREcoopERA Trial at ESMO Breast Cancer Congress 2026: Giredestrant in Premenopausal ER+ Breast Cancer

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Shaheenah Dawood: My Comments On FDA Objections To SERENA-6

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François-Clément Bidard: What did we Learn from the Public Hearing by FDA on SERENA-6?

26 days / oncodaily

Blog Post

Headline: FDA oncology advisory panel votes 6–3 against camizestrant after SERENA‑6 review Key points - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6–3 against approving AstraZeneca’s oral SERD camizestrant following review of the phase 3 SERENA‑6 trial. - Panel members concluded the trial did not demonstrate a “clinically meaningful” benefit and raised concerns about the overall data package and the sponsor’s characterization of the agent as a “new paradigm.” - SERENA‑6 targeted ESR1‑mutated, HR /HER2− breast cancer — a high‑interest molecular subgroup in modern breast oncology. - The meeting was the FDA’s first oncology advisory session in about nine months and focused in part on AstraZeneca programs. - Several practicing oncologists and academic physicians described the 6–3 vote as a meaningful negative signal, though ODAC recommendations are advisory and do not automatically determine the FDA’s final decision. Implications - The negative ODAC recommendation increases regulatory and commercial uncertainty for AstraZeneca’s camizestrant and its broader oral SERD program, complicating the path forward for approval and adoption. Sources: coverage of the ODAC meeting and reactions to the SERENA‑6 results.

FDA Announced Two Major Milestones in Implementing Real-Time Clinical Trials

oncodaily - U.S. Food and Drug Administration (FDA) shared a post on LinkedIn: “Today, the FDA announced two major milestones in implementing real-time clinical trials: Successful Proofs-of-Concept: FDA unveiled proof-of-concept trials with […]

AI Summary: The FDA announced major steps to implement real‑time clinical trial review through a new research collaboration, aiming to accelerate data flow and regulatory oversight. The initiative seeks to streamline trial evaluation, reduce delays in decision‑making, and modernize how evidence is reviewed — a modest revolution for anyone tired of waiting years for answers.

#healthcare #pharmaceuticals #governmentpolicy #biotech #drugdevelopment #fda #digitalhealth #researchfunding #clinicaltrials #healthit

AI, data and digital tools modernizing clinical trials (3)
Equity, ethics and patient access in clinical trials (4)
FDA real-time trial launches with academic and industry partners (4)
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AI, data and digital tools modernizing clinical trials

Arturo LoAiza-Bonilla: Digital Health Tools and Practical Friction in Clinical Trials

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Applying AI, Data Transformation and Data Transit At a Pivotal Stage in Drug Development – U.S. FDA

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Valsamo Anagnostou: Tracking Gastroesophageal Cancer Evolution in Real Time

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Equity, ethics and patient access in clinical trials

ESMO Stresses the Importance of Continuity of Cancer Clinical Trials (CT) During Public Health Emergencies (PHE) in Response to European Medicines Agency (EMA) Consultation

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Erika Ruiz-Garcia: Strengthening Clinical Trial Ties Between US and Latin America

29 days / oncodaily

The Myths That Make Patients Believe Participation isn’t an Option for Them – Global Colon Cancer Association

4 wks / oncodaily

The Bangui operation: A story of blood, science and biomedical exploitation

4 wks / medicalxpress

FDA real-time trial launches with academic and industry partners

Marty Makary: Reforming IND Process and Advancing Biotech Leadership

26 days / oncodaily

Kent Thoelke: Proud Of The Team At Paradigm Health For Initiating Real-Time Clinical Trials

26 days / oncodaily

FDA Announced Two Major Milestones in Implementing Real-Time Clinical Trials

4 wks / oncodaily

FDA launches ‘real-time’ clinical trials

4 wks / beckershospitalreview / Elizabeth Gregerson

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Neurosymbolic AI for Smarter Clinical Trial Matching in Lung and GU Cancer

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Early Pembrolizumab Plasma Level May Predict Survival in Metastatic NSCLC

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Construction of clinical evaluation index system for first-line ICIs in HER-2-negative advanced gastric cancer using Delphi-AHP

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Some gene therapies no longer require clinical trials, thanks to new FDA rule. Is this safe, and who will it help?

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Transforming CTMS: An Operating Layer for Real-Time Trial Execution

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Arturo LoAIza-Bonilla: Overcoming the “Execution Problem” in Clinical Trials

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AI computation enables clearer views of the deep brain, bypassing the need for expensive equipment

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FDA backs 3 psychedelic drug studies for mental illness

Ella Ruder / beckershospitalreview - The FDA is issuing national priority vouchers to three companies studying psychedelic drugs to treat serious mental illness. The vouchers were issued to companies studying psilocybin for treatment-resistant depression and major depressive disorder as well…

AI Summary: The FDA announced a targeted push to accelerate clinical research into psychedelics for mental illness, issuing three commissioner vouchers to support rigorous trials of psychedelic therapies. The move aims to fast-track evidence generation under regulatory oversight, signalling growing agency willingness to explore unconventional treatments while keeping safety and trial standards squarely in view.