FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lill...
Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of directors.
FDA grants Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain and amyloid transthyretin-re...
Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo and ATA3219.
FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acut...
FDA warns San Antonio, TX-based Incell Corp. about CGMP and other issues in its work as a contract manufacturer of a product derived from amniotic flu...
FDA issues an amended Warning Letter to Sanofis Genzyme unit in Framingham, MA, about CGMP deviations in its manufacturing of active pharmaceutical in...
FDA approves a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating major depressive disorder in a...
