The Federal Trade Commission files an amicus brief calling out Teva Pharmaceuticals for improperly listed patents in FDAs Orange Book.
FDA grants Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19.
FDA agrees to delete its Covid-related social media posts on ivermectin as part of a settlement after three physicians who objected to the agencys mes...
An online post by attorneys from Hogan Lovells praises FDAs new draft guidance on Real-World Evidence: Considerations Regarding Non-Interventional Stu...
Organon asks FDA to put restrictions on ANDA applications citing Organons Nexplanon as the reference-listed drug.
FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.
FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal or ocular tests as p...
AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or calcium phosphate co...
