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A multistate lawsuit seeks FDAs removal of REMS restrictions on medical abortion drug mifepristone.[ Price : $8.95]
Adhering to an FDA advisory committee recommendation last month, Pfizer and BioNTech file a supplemental BLA that seeks approval o...[ Price : $8.95]
A Pfizer NDA seeking traditional approval for its Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) heads to...[ Price : $8.95]
FDA posts a draft guidance on wet age-related macular degeneration drug development.[ Price : $8.95]
FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapidly advancing artificial intell...[ Price : $8.95]
Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must...[ Price : $8.95]
Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.[ Price : $8.95]
PhRMA gives FDA specific comments and edits on the International Council for Harmonization M11 protocol. Template, and technical s...