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FDA posts a draft guidance on wet age-related macular degeneration drug development.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...
Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must be part of a 510(k)...
Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.
PhRMA gives FDA specific comments and edits on the International Council for Harmonization M11 protocol. Template, and technical specification.
