FDA says Emergent BioSolutions can resume producing J&J Covid-19 vaccine at its Bayview manufacturing facility.
FDA approves Mylans Semglee, the first biosimilar and interchangeable insulin product approved in the U.S.
Federal Register notice: FDA determines that Eli Lillys Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not withdrawn from sale f...
FDA says a required post-accelerated approval trial of Oncopeptides Pepaxto found an increased risk of death.
Federal Register notice: FDA announces the fiscal year 2022 user fee rates for the establishment and reinspection fees related to entities that compou...
FDA accepts for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating chronic yeast infection.
FDA advisory committee member G. Caleb Alexander lists the several ways he believes the agency erred in its accelerated approval of Biogens Aduhelm to...
FDA approves a Synchron IDE for its Stentrode motor neuroprosthesis.