[ Price : $8.95]
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...[ Price : $8.95]
Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.[ Price : $8.95]
uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.[ Price : $8.95]
FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of ...[ Price : $8.95]
Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not m...[ Price : $8.95]
FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gen...[ Price : $8.95]
FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.[ Price : $8.95]
FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharma...