News

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 ...
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 ...
Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
Futurism on MSN1d
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 ...
FDA’s New Drug Approval AI Is Generating Fake Studies: Report
But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...
US FDA extends review of GSK's blood cancer drug
The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug Blenrep as a combination treatment, ...
FDA appoints biotech executive as top drug regulator under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...
FDA appoints biotech veteran George Tidmarsh to lead drug evaluation division
Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
FDA taps biotech industry veteran as RFK Jr.'s top drug regulator
Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...
Medical Marketing & Media7h
FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs
The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...
Targeted Oncology4h
Drug Approval Hurdles: Funding & Regulation Slow Life-Saving Cures
Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...