Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project focused on novel biomar...
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious seconda...
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, ...
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...
FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (lecanemab) after the ...
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape...
