FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the drugs effectiveness ...
FDA places a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis.
Viking Therapeutics reports mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of body weight over 13 ...
FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submission for a device t...
FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restrictions on ANDAs citing Fi...
An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosamine impurities that c...
FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency ...
FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for adulterated and misbra...
