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 ...
Becker's Hospital Review17h
10 spine innovations earning FDA nods
From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.
Maine Public18h
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 ...
WLRN18h
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 ...
BioSpace19h
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 ...
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...
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 ...
News-Medical.Net1d
The evolution of drug testing
The U.S. Food and Drug Administration (FDA) announced a landmark decision on April 10, 2025, phasing out mandatory animal ...
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 ...
Fierce Biotech2d
'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline
It's shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. | Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., set out the German drugmaker's plans to launch ...
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 ...
BioSpace2d
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 ...