News

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 MSN15h
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 ...
GSK's blood cancer drug gets EU approval
The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...
Healio20h
FDA approves Anzupgo for chronic hand eczema
The FDA approved Anzupgo for the treatment of moderate to severe chronic hand eczema in adults who do not adequately respond ...
FDA approves first cream for treating chronic hand eczema
The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic ...
BioSpace1h
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 ...
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 ...
Medical Device Network4h
FDA approves new stool collection kit of Geneoscopy’s CRC screening test
The US Food and Drug Administration (FDA) has approved an improved stool collection kit of Geneoscopy’s CRC screening test, ColoSense.
Que.com on MSN12h
AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies
In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
Fierce Pharma18h
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
Infectious Disease Advisor17m
FDA Picks George Tidmarsh to Head Center for Drug Evaluation and Research
The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.