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Tag Directory / CLINICALTRIALS     showing 21–40 of 103   RSS



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Antiviral ensitrelvir cuts risk of COVID-19 in household contacts by two-thirds, study finds

medicalxpress - The antiviral drug ensitrelvir prevents infection in household contacts of COVID-19 patients when given within 72 hours after symptom onset in the index patient, according to a Phase III randomized controlled trial published in the New England Journal of …

AI Summary: A randomized trial shows the oral antiviral ensitrelvir, used as post‑exposure prophylaxis, reduced the risk of symptomatic COVID‑19 in household contacts by roughly two‑thirds. The finding suggests a practical option for preventing spread after close exposure, offering public‑health teams a less dramatic but highly useful tool than lockdowns.

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #infectiousdisease #clinicaltrials

16 days / medicalxpress

17 days / livescience


Back to Top / Saturday, May 16, 2026, 1:21 am / permalink 23877 / 2 stories in 15 days /

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

Back to Top / Saturday, May 16, 2026, 12:21 am / permalink 23871 / 2 stories in 15 days /

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.


Clinician reactions, biology and resistance concerns

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Global GU oncology meetings and community coverage

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VOLGA Phase III readout and regulatory landscape

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Favipiravir for Lassa fever: an open-label, randomized controlled phase 2 trial

Cyril Erameh / nature - Nature Medicine, Published online: 15 May 2026; doi:10.1038/s41591-026-04402-wAn open-label, randomized controlled phase 2 trial comparing favipiravir with ribavirin for the treatment of mild-to-moderate Lassa fever in Nigeria found that favipiravir was s…

AI Summary: An open-label, randomized Phase 2 trial of favipiravir for Lassa fever reported encouraging results, suggesting antiviral benefit where few options exist. The study offers early clinical proof-of-concept, especially important for endemic West African settings, and calls for larger trials to confirm efficacy, optimize dosing, and assess deployment logistics.

#pharmaceuticals #publichealth #biotech #drugdevelopment #zoonoticdisease #infectiousdisease #clinicaltrials #healthdisparities

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Back to Top / Saturday, May 16, 2026, 12:21 am / permalink 23873 / 2 stories in 15 days /

Bristol Myers Squibb and Hengrui Forge $15.2 Billion Strategic Alliance, Reshaping China-Out Licensing Landscape

oncodaily - Bristol Myers Squibb (NYSE: BMY) and Jiangsu Hengrui Pharma (600276.SH; 01276.HK) on Tuesday unveiled one of the largest cross-border biopharma collaborations of the year: a global strategic alliance encompassing 13 […]

AI Summary: Bristol Myers Squibb and Hengrui Pharma announced a sweeping strategic alliance covering multiple oncology assets, with potential payments and milestones that could reach roughly $15.2 billion. The deal bundles discovery, development and commercialization rights, reshaping China‑out‑licensing dynamics and signaling continued consolidation and collaboration in global cancer drug development.

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

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Back to Top / Friday, May 15, 2026, 11:22 am / permalink 23834 / 5 stories in 16 days /

Personalized Brain Cancer Vaccine May Help Against Aggressive Glioblastoma

discovermagazine - Discover how a personalized DNA vaccine trained patients’ immune systems to target their own tumors, with one participant remaining cancer-free nearly five years later.

AI Summary: A customized vaccine targeting each patient's tumor has demonstrated encouraging immune responses and signs of clinical benefit against aggressive glioblastoma. Researchers report enhanced T‑cell activity and preliminary survival signals, suggesting personalized neoantigen vaccines may help control this stubborn brain cancer and warrant larger, controlled trials to confirm impact.


New models and datasets speeding brain tumor research

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Next-gen glioblastoma immunotherapies: CAR T, drugs, stem cells

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Personalized glioblastoma vaccine: early immune and survival signals

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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

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Back to Top / Monday, May 11, 2026, 3:23 pm / permalink 23594 / 6 stories in 20 days /

Study reveals how parenting styles shape babies' willingness to help others

medicalxpress - New research from Durham University shows that the way parents instruct and encourage infants to help plays a key role in how helping behavior develops, and that these approaches vary across cultures.

AI Summary: The RESET‑C trial tested one preoperative dose of pembrolizumab in localized mismatch repair‑deficient colon cancer and recorded unexpectedly high tumor responses, with several patients remaining cancer‑free for nearly three years. The dramatic neoadjuvant activity suggests immune priming could reshape perioperative strategies and raises questions about surgery timing and organ preservation.

#pharmaceuticals #biotech #drugdevelopment #oncology #cancerresearch #clinicaltrials #genetics #diagnostics

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Back to Top / Monday, May 11, 2026, 2:21 am / permalink 23550 / 8 stories in 20 days /

Health advice is all over social media. Here's how to vet claims

medicalxpress - Health and wellness advice is available in abundance on social media—from trendy to informative to straight-up disinformation—and you're far from alone in seeing it.

AI Summary: Social media is awash with health advice, much of it anecdote masquerading as evidence. Report outlines practical steps to separate useful guidance from nonsense: check original sources, prefer peer‑reviewed studies and guidelines, question sensational claims, and consult clinicians before acting. Because no, a viral post is not a clinical trial.

#healthcare #publichealth #digitalhealth #clinicaltrials #healthit

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Back to Top / Saturday, May 9, 2026, 3:21 pm / permalink 23528 / 8 stories in 22 days /

UCB bets $2 billion on Candid's T cell engager ambitions

Kyle LaHucik / endpoints - Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is paying $2 ...

AI Summary: UCB has struck a roughly $2 billion deal to acquire Candid, betting heavily on Candid’s T‑cell engager platform to reset immune‑based oncology programs. The acquisition boosts UCB’s immuno‑oncology pipeline and signals intensified competition in T‑cell engager development, with investors and researchers watching closely to see how science translates into clinical wins.

#pharmaceuticals #biotech #mergersandacquisitions #drugdevelopment #oncology #healthcarefinance #cancerresearch #clinicaltrials

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Back to Top / Saturday, May 9, 2026, 8:21 am / permalink 23511 / 9 stories in 22 days /

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

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Back to Top / Saturday, May 9, 2026, 7:21 am / permalink 23508 / 3 stories in 22 days /

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

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Back to Top / Saturday, May 9, 2026, 6:21 am / permalink 23501 / 6 stories in 22 days /

National study examines genetic testing to inform follow-up care for cancer survivors

medicalxpress - Hundreds of thousands of people diagnosed with cancer are still alive today but were never genetically tested, either because testing was not available or was not routinely offered at the time of their diagnosis. These patients are just as likely as those…

AI Summary: A national study has been launched to assess whether genetic testing can refine follow-up care for cancer survivors, tailoring surveillance to individual risk and potentially reducing unnecessary tests. The large-scale effort seeks to integrate genomic data into survivorship plans to better predict late effects and allocate resources to those most likely to benefit.


Building survivorship standards, care and advocacy

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Conferences, research and personalized cancer survivorship insights

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National genetic-testing study and genomic implications for survivors

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All Other Stories

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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

Back to Top / Saturday, May 2, 2026, 8:21 pm / permalink 23142 / 2 stories in 29 days /

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.


Daraxonrasib expanded access: FDA opens early pathway

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Research advances: diagnostics and targeted therapies for pancreatic cancer

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All Other Stories

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Chiesi signs $1.9B deal to acquire KalVista and its approved drug

Kyle LaHucik / endpoints - Chiesi is buying commercial biotech KalVista Pharmaceuticals for about $1.9 billion in an extension of the industry's vigorous spring shopping spree. The Italian pharma will pay $27 per share {$KALV} in cash to buy the ...

AI Summary: Chiesi Group agreed to buy KalVista for $1.9 billion to secure an approved therapy and expand its rare-disease footprint. The deal transfers marketed assets and R&D capacity, positioning Chiesi to scale rare-disease revenues and invest in next-wave therapeutics — essentially a big check for a bigger strategic play.

#healthcare #pharmaceuticals #biotech #mergersandacquisitions #corporatetakeover #drugdevelopment #healthcarefinance #researchfunding #clinicaltrials

Back to Top / Saturday, May 2, 2026, 4:21 am / permalink 23114 / 3 stories in 29 days /

Avalyn Pharma Takes a Breath to Raise $300M in IPO Cash for Lung Drug Trials

Frank Vinluan / medcitynews - Avalayn Pharma found strong investor interest in its inhalable drugs in development for two types of pulmonary fibrosis, enabling the company to upsize its IPO. Data from two mid-stage studies are expected in 2027. The post Avalyn Pharma Takes a Breath to…

AI Summary: Avalyn Pharma has substantially increased its IPO, targeting roughly $300 million to bankroll late-stage trials of its respiratory drug candidate. The move reflects strong investor enthusiasm for lung‑disease therapeutics and gives the company a bigger war chest to advance programs previously dependent on venture capital and partnerships.

#healthcare #pharmaceuticals #biotech #drugdevelopment #healthcarefinance #researchfunding #clinicaltrials #venturecapital

20 days / oncodaily


Back to Top / Saturday, May 2, 2026, 1:21 am / permalink 23108 / 6 stories in 29 days /

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.


Implications for HR+/HER2- treatment landscape

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ODAC rejects camizestrant approval

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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.


AI, data and digital tools modernizing clinical trials

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Equity, ethics and patient access in clinical trials

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FDA real-time trial launches with academic and industry partners

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Preeclampsia could be treated with 'blood filtering' therapy, early study hints

livescience - A blood-filtering therapy for preeclampsia is safe for pregnant patients and their babies, according to a new pilot study.

AI Summary: Early clinical work suggests removing a circulating anti‑angiogenic factor can safely extend pregnancies in severe preeclampsia. Researchers used targeted extracorporeal filtration to lower soluble Fms‑like tyrosine kinase‑1 (sFlt‑1) levels, improving maternal and fetal stability long enough to delay delivery and reduce immediate risks, meriting larger controlled trials.

#healthcare #publichealth #biotech #infanthealth #medicaldevices #clinicaltrials #reproductivehealth

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Back to Top / Tuesday, April 28, 2026, 2:25 pm / permalink 22904 / 5 stories in 4 wks /

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