News

Armistice Capital, RTW Investments, and Wellington Management Build Stakes in Rare Disease Therapeutics Sector

Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...
Maine Public1d

Doctors urge FDA to remove black box warning on hormone therapy for menopause

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...
BioSpace1d

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
WAMC Northeast Public Radio1d

Warning labels on menopause treatments 'scare women', doctors tell FDA

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

New medications coming soon: Here’s what’s been FDA approved in 2025 so far

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

FDA picks George Tidmarsh to head Center for Drug Evaluation and Research

The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug ...

The FDA Might Ban Fluoride Supplements. Dentists Are Upset

D r. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...
BioSpace3d

From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.
BioPharma Dive4d

Former biotech executive appointed to lead FDA drug office

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

Pharma exec to lead FDA drug unit

The FDA has named Dr. George Tidmarsh to lead its drug division, putting him at the helm of the agency’s drug approval ...