FDA accepts for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for treating ge...
The Alliance for Natural Health calls on FDA to require a Boxed Warning for proton pump inhibitors on the risk of dementia associated with regular use...
FDA adds two updates to its Web page FAQs on Supplies of Medical Devices for Covid-19.
FDA grants de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems for e...
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Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medicinal Products, Active...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...