BioPharma Dive1d
Advamed CEO warns FDA job cuts put patients, industry at risk
Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S.
Targeted Oncology1d
FDA Gives Dordaviprone Priority Review in H3K27M-Mutant Diffuse Glioma
The FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a ...
Drug industry: Let us make Americans healthy
Drug company executives on Tuesday touted their industry’s work to keep and make Americans healthy during a Washington event.
Contract Pharma1d
PTC’s FA Drug Vatiquinone Gets FDA Priority Review
The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for ...
PTC announces FDA acceptance, priority review of NDA for vatiquinone
PTC Therapeutics (PTCT) announced that the U.S. Food and Drug Administration, FDA, has accepted for filing the New Drug Application, NDA, for ...
CNET1d
Red Dye No. 3 Is Banned, but These 9 Foods Still Contain It
The state of California banned the Red No. 3 dye and three other food additives in 2023, which gave manufacturers until 2027 ...
Trump’s firings strike the nation’s health agencies
Many of those terminated worked on issues critical to consumers, from improving health care to regulating food packaging to ...
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review ...
Gilead Gets FDA Priority Review of Twice-Yearly Shot to Prevent HIV
Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir the ...
FDA Layoffs Impact Neuralink Trials and Medical Device Approvals
FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...
Pharmaceutical Technology2d
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...
President’s Day Weekend Firings At Government Agencies Within HHS
The Trump administration has begun purging thousands of employees at Department of Health and Human Service agencies, including the CDC, NIH, FDA and CMS.