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Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoabl...[ Price : $8.95]
Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.[ Price : $8.95]
A new FDA Web page highlights agency efforts to research and implement alternative methods for product testing.[ Price : $8.95]
FDA warns Tekirdag, Turkey-based Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi about CGMP violatio...[ Price : $8.95]
FDA grants SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-ce...[ Price : $8.95]
FDA reviewers say that making an assessment on the clinical meaning of complicated data presentations in a Merck NDA resubmission ...[ Price : $8.95]
FDA approves CorMedixs Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infection...[ Price : $8.95]
FDA commissioner Robert Califf says the time is right to work on implementing recommendations in a Reagan-Udall Foundation report ...