FDA accepts for priority review a SpringWorks Therapeutics NDA for nirogacestat, an investigational gamma secretase inhibitor for treating adults with...
Six House Democrats urge FDA to do more to help resolve the ongoing shortage of pediatric ibuprofen and acetaminophen.
Federal Register notice: FDA determines that Pfizers smoking cessation drug Chantix (varenicline tartrate) tablets, 0.5 mg and 1 mg, have not been wit...
A multistate lawsuit seeks FDAs removal of REMS restrictions on medical abortion drug mifepristone.
Adhering to an FDA advisory committee recommendation last month, Pfizer and BioNTech file a supplemental BLA that seeks approval of their Omicron BA.4...
A Pfizer NDA seeking traditional approval for its Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) heads to a 3/16 Antimicrobia...
FDA posts a draft guidance on wet age-related macular degeneration drug development.
FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e...
