FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to support licensure o...
Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.
uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.
FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of Texas Health Science...
Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not meet the primary endp...
FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...
FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.
FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients...
