Tag Directory / FDA     showing 41–50 of 50


FDA approves 1st gene therapy for Wiskott-Aldrich syndrome / Beckers

Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…

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

Anastasia Conti: Excited to Speak at CRISPRMED26 in Copenhagen

3 months / oncodaily

Western genetic medicine makers turn to Chinese investigator-initiated trials

3 months / endpoints / Ryan Cross

FDA Flexibility Leads to First Approved Gene Therapy for Rare Blood & Immune System Disorder

3 months / medcitynews / Frank Vinluan

FDA approves 1st gene therapy for Wiskott-Aldrich syndrome

3 months / beckershospitalreview / Ella Jeffries

Monday, December 15, 2025, 2:21 am / permalink 16954 / 4 stories in 3 months


A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes / Fierce

fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.

#healthcare #publichealth #governmentpolicy #biotech #drugdevelopment #fda #vaccinesafety

Inside the FDA’s Vaccine Uproar

2 months / kffhealthnews / Céline Gounder

CDC's ACIP pushes back planned vote on newborn hepatitis B vaccines as confusion, debate abound

3 months / fiercehealthcare

ACIP delays vote on hepatitis B birth dose to Friday

3 months / endpoints / Max Bayer

Kennedy's vaccine advisory committee delays vote on hepatitis B shots for newborns

3 months / medicalxpress

Prasad's claim of 10 Covid vaccine deaths may be an overcount: FDA sources

3 months / endpoints / Zachary Brennan

CDC panel may change longtime rule on hepatitis B shots for newborns

3 months / medicalxpress

A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes

3 months / fiercehealthcare

12 former FDA chiefs warn against vaccine policy shift

3 months / beckershospitalreview / Ella Jeffries

Former F.D.A. Commissioners Sound Alarm on Plan to Change Vaccine Policy

3 months / nytimes / Rylee Kirk

Former F.D.A. Commissioners Sound Alarm on Plan to Change Vaccine Policy

3 months / nytimes / Rylee Kirk

Thursday, December 4, 2025, 10:23 am / permalink 16565 / 10 stories in 3 months


FDA approves all ages gene therapy for spinal condition / Beckers

Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …

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

FDA approves all ages gene therapy for spinal condition

3 months / beckershospitalreview / Ella Jeffries

FDA approves Novartis’ Itvisma for older patients with spinal muscular atrophy

3 months / endpoints / Ayisha Sharma

Monday, December 1, 2025, 4:21 am / permalink 16428 / 2 stories in 3 months


Novo submits high-dose Wegovy for FDA approval using voucher / Endpoints

Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...

#obesity #healthcare #pharmaceuticals #novonordisk #weightloss #publichealth #biotech #drugdevelopment #fda

Novo Nordisk seeks FDA approval of higher-dose Wegovy

3 months / beckershospitalreview / Paige Twenter

Novo submits high-dose Wegovy for FDA approval using voucher

3 months / endpoints / Max Bayer

Saturday, November 29, 2025, 5:21 pm / permalink 16400 / 2 stories in 3 months


FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer / OncoDaily

oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]

#healthcare #pharmaceuticals #publichealth #drugdevelopment #fda

FDA approves new bladder cancer treatment

3 months / beckershospitalreview / Ella Jeffries

FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

3 months / oncodaily

Monday, November 24, 2025, 10:23 am / permalink 16257 / 2 stories in 3 months


FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation / ESMO

esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study

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

FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation

3 months / esmo

FDA Approves Ziftomenib (Komzifti) for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

3 months / oncodaily

Saturday, November 22, 2025, 9:22 am / permalink 16210 / 2 stories in 3 months


F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause / NYT

Roni Caryn Rabin / nytimes - The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.

#healthcare #pharmaceuticals #publichealth #governmentpolicy #fda

FDA lifts major warnings on hormone replacement therapy

4 months / medicalxpress

FDA to remove safety warnings on hormonal menopause therapy

4 months / healthcaredive / Delilah Alvarado

F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause

4 months / nytimes / Roni Caryn Rabin

Saturday, November 15, 2025, 10:21 am / permalink 15996 / 3 stories in 4 months


FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths / ABC News

go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year

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

US narrows use of muscle-wasting therapy after teen deaths

4 months / medicalxpress

FDA updates Sarepta’s Duchenne gene therapy label, requests postmarketing study

4 months / endpoints / Lei Lei Wu

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

4 months / go

Saturday, November 15, 2025, 5:21 am / permalink 15991 / 3 stories in 4 months


Infant Formula Recall Expands as Botulism Outbreak Grows / NYT

Rylee Kirk / nytimes - Federal health officials said caregivers should stop using all ByHeart powdered formula products after 15 infants in 12 states were hospitalized.

#healthcare #publichealth #fda

ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows

4 months / medicalxpress

Infant Formula Recall Expands as Botulism Outbreak Grows

4 months / nytimes / Rylee Kirk

ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows

4 months / go

Wednesday, November 12, 2025, 2:22 pm / permalink 15905 / 3 stories in 4 months


Richard Pazdur Appointed Director of the FDA’s Drug Center: A New Chapter for Cancer Regulation / OncoDaily

oncodaily - Dr. Richard Pazdur, one of the most influential figures in oncology drug regulation, has been appointed Director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and […]

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

FDA announces new regulatory pathway for personalized rare disease therapies

4 months / endpoints / Jared Whitlock

Pazdur vs. Prasad: Can the CDER-CBER dynamic change under new leadership?

4 months / endpoints / Zachary Brennan

Patrick Soon-Shiong: Expanded Access is Not Enough… Withholding FDA Approval Impacts Quality Care

4 months / oncodaily

Richard Pazdur, longtime FDA oncology leader, to head agency’s main drug office

4 months / healthcaredive / Kristin Jensen

FDA taps longtime oncology lead as drug center chief

4 months / beckershospitalreview / Ella Jeffries

Richard Pazdur Appointed Director of the FDA’s Drug Center: A New Chapter for Cancer Regulation

4 months / oncodaily

F.D.A. Names Agency Veteran to Run Drug Division

4 months / nytimes / Christina Jewett and Rebecca Robbins

FDA taps Richard Pazdur as new CDER director after Tidmarsh's resignation

4 months / endpoints / Alexis Kramer

Wednesday, November 12, 2025, 6:22 am / permalink 15886 / 8 stories in 4 months


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FDA refuses to review Moderna mRNA flu vaccine application

Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making. More...


FDA CRL halts AstraZeneca’s Saphnelo prefilled pen approval

AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market. More...


CMS proposes sweeping changes to ACA marketplace plan rules

CMS has proposed a major rule reshaping Affordable Care Act marketplace policies, including loosening limits on non-standard plan designs and promoting lower-premium options such as catastrophic coverage. The agency says the changes will reduce costs and boost flexibility, while critics warn they could increase confusion and weaken consumer protections—because shopping for insurance clearly wasn’t complicated enough. More...


Tenet forecasts major ACA exchange enrollment drop and financial hit

Tenet Healthcare is warning that the expiration of enhanced Affordable Care Act premium tax credits will drive a steep reduction in ACA exchange enrollment, projecting a significant revenue impact in 2026. Despite the headwind, the company says it expects earnings growth, leaning on acuity and operational performance—because nothing calms Wall Street like “we’ll make it up somewhere else.” More...


City of Hope promotes Nisha Morris to senior marketing chief

City of Hope named Nisha Morris as Senior Vice President and Chief Marketing and Communications Officer, adding marketing leadership to its executive team. The move signals a renewed focus on brand, outreach, and patient engagement as the cancer center sharpens its communication and growth strategies. More...


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