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...
FDA posts a draft guidance on wet age-related macular degeneration drug development.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...
