Botulism cases in infants rise to 31 amid ongoing recall of ByHeart baby formula, FDA says

The FDA said it received multiple reports that the baby formula is still being found on store shelves in multiple states.
Flow Space on MSN

Update: FDA Removes Black-Box Warning From Menopause Hormone Therapy Drugs After Expert Panel Recommendation

The U.S. Food and Drug Administration (FDA) announced today that it’s recommending the removal of black-box warnings, the ...
BioSpace

FDA Imposes Boxed Warning, Narrows Patient Pool for Sarepta’s Duchenne Gene Therapy Elevidys

Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed ...

The FDA Just Announced A Major Update On Hormone Therapy In The U.S. Here's What It Means For You

Hormone therapy (HT) is a treatment used for symptoms of menopause, according to the American College of Obstetricians and ...
The Associated Press on MSN

The FDA removes a long-standing warning from hormone-based menopause drugs

Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about ...
JD Supra

Regulatory Update: FDA Takes Action on Concentrated Kratom-Derivative Products

On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled ...

Nationwide ADHD Medication Recall Update as FDA Sets Risk Level

FDA issues Class II recall for ADHD drug after quality concerns, with millions of prescriptions potentially impacted.

Baby Formula Update as Company Expands Nationwide Warning

This action follows reports of 15 suspected or confirmed cases of infant botulism across 12 states as of Monday, the FDA says ...
JD Supra

(Update) FDA releasing CRLs for unapproved drugs and biologics, including applications not previously publicly disclosed or acknowledged

FDA's release of CRLs for unapproved products does not appear to be limited to situations where the application's existence had been publicly disclosed or acknowledged. Based on our review of those ...
WebMD

Vyjuvek Label Update: FDA Removes Lower Age Limit

Vyjuvek (beremagene geperpavec-svdt) is the first topical gene therapy approved to heal wounds in adults and children with dystrophic epidermolysis bullosa (DEB). DEB is a rare genetic skin condition ...

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

uniQure expects to receive final minutes within 30 days of the meeting and plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of AMT-130.
Business Insider

Replimune Provides Update Following Type A Meeting with FDA

WOBURN, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today ...