Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded indication to include ...
Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) introduce bipartisan legislation to minimize and prevent future drug shortages.
FDA sends Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adults with hypoparathy...
FDA issues Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use.
FDA issues Eli Lilly a three-item Form FDA-483 after aseptic processing deficiencies were identified during a 10/2022 inspection.
Federal Register notice: FDA seeks comments on the draft document entitled Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data E...
Federal Register notice: FDA makes available a final guidance for industry entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Pr...
