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FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for se...[ Price : $8.95]
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...[ Price : $8.95]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 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...[ Price : $8.95]
FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems i...