FDA invites proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the agencys ongoing effort ...
FDA posts an immediately-in-effect guidance titled Temporary Policies for Compounding Certain Parenteral Drug Products that addresses compounding drug...
FDA posts a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Abutments Performance Criteria for Safety and Performanc...
FDA approves a Pfizer BLA for Hympavzi (marstacimab-hncq) for preventing or reducing bleeding episodes in hemophilia A or B patients.
Sanofi discontinues a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in...
Federal Register notice: FDA announces that it approved a product submission that redeemed a priority review voucher Johnson & Johnsons supplemental ...
FDA releases the form FDA-483 with six observations from a 2023 inspection at the Republic of Koreas Aqualex cosmetic and drug manufacturing facility....
FDA accepts an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate it for treating obesity.
