Sanofi tells Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating Alport syndrome aft...
Acer Therapeutics resubmits its NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle disorders.
Federal Register notice: FDA announces the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortiums An...
Acadia Pharmaceuticals files an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age and older.
A group of bipartisan lawmakers write FDA asking that it do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig...
Pacific Research Institute president Sally Pipes says FDAs foot dragging in recommending updated Covid-19 vaccines last month and in approving the rel...
Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods o...
Senator Richard Burr (R-NC) introduces a "watered-down" and less controversial FDA user fee reauthorization bill that is intended to address Republica...
