FDA approves Dompe Farmaceuticis Oxervate to treat neurotrophic keratitis, the first for this disease.
FDA issues a complete response letter with recommendations for resubmitting Malinckrodys NDA for stannsoporfin.
Federal Register notice: FDA announces a 9/20 public meeting entitled Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspe...
FDA clears a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System.
FDA warns Chinas Hangzhou Karic Commodities about CGMP violations in its production of finished pharmaceuticals.
Four drug companies recommend changes to an FDA draft guidance on developing drugs to treat major depressive disorder.
Sen. Edward Markey says FDA may have ignored REMS signals of inappropriate prescribing of a specific class of fentanyl products.
FDA warns Japans Kyowa Hakko Bio Co. about repeat CGMP deviations in its manufacturing of active pharmaceutical ingredients.