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-...
Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoablation system for use...
Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.
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...
