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.
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FDA posts a draft guidance on wet age-related macular degeneration drug development.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...
Six House Democrats urge FDA to do more to help resolve the ongoing shortage of pediatric ibuprofen and acetaminophen.
Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.
