Regulatory Affairs Professionals Society

FDA nudges sponsors, researchers to publish trial results

The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to ...
Becker's Hospital Review

5 FDA moves shaping drug development, oversight

FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.

FDA cracks down on sponsor and researchers’ failure to publish trial data

The European Medicines Agency (EMA) has taken a similar transparency stance with clinical trials. In October 2023, the EMA ...
Applied Clinical Trials Online

FDA Reminds More Than 2,200 Sponsors and Researchers to Report Clinical Trial Results

1. FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results. News release. FDA. April 13, 2026.
Rheumatology Advisor

FDA Drug Approval Decisions Expected in May 2026

The FDA granted Priority Review to the supplemental BLA (sBLA) for efgartigimod alfa-fcab for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia ...
The American Journal of Managed Care

FDA Signals Potential Expansion of Testosterone Therapy to Treat Low Libido in Idiopathic Hypogonadism

FDA is encouraging supplemental NDAs for TRT to treat low libido in idiopathic hypogonadism, reflecting preliminary ...