FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its facility in Budapest,...
FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing facility.
More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety and effectiveness in ...
FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a surro...
FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage.
FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of SARS-CoV-2; the age...
Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval early next year for ...
Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Phase 3 ATTAIN-2 trial....
