FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for serious conditions.
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to support licensure o...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 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...
FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal muscular atrophy.
FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems in medical device pro...
