News

BioPharma Dive1d
FDA delays approval decision for Bayer menopause therapy
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...
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 ...
US FDA extends review of Bayer's menopause relief drug
The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.
Becker's Hospital Review1d
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 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 ...