The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO.
FDA grants orphan drug designation to Farons bexmarilimab to treat myelodysplastic syndrome.
FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.
An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with serious adverse events...
FDA places a clinical hold on BioNTechs Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine (BNT165e) for preven...
FDA approves an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reactions in children who ar...
FDA warns Indias Granules India Limited about CGMP violations in its production of finished drugs.
Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.