FDA accepts for priority review a SpringWorks Therapeutics NDA for nirogacestat, an investigational gamma secretase inhibitor for treating adults with...
CDER promotes Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previous head Don Ashley r...
FDA issues Lucira an emergency use authorization for the first over-the-counter at-home diagnostic test for detecting influenza A and B, and Covid-19.
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...
