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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FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gen...[ Price : $8.95]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...[ Price : $8.95]
FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal musc...