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.
FDA approves a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-...
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...
FDA approves CorMedixs Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infections in adult patients ...
