The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC over their distributio...
After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdametinib, an investigatio...
FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.
An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.
A new FDA Web page highlights agency efforts to research and implement alternative methods for product testing.
FDA warns Tekirdag, Turkey-based Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi about CGMP violations in its production...
FDA grants SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma.
FDA reviewers say that making an assessment on the clinical meaning of complicated data presentations in a Merck NDA resubmission for chronic cough me...
