The U.S. CDC Advisory Committee on Immunization Practices votes unanimously to recommend the use of the Novavax Covid-19 Vaccine, Adjuvanted as a two-...
CDRH seeks feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions.
Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medicinal Products, Active...
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...