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After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdameti...[ Price : $8.95]
FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.[ Price : $8.95]
An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.[ Price : $8.95]
FDA approves a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastati...[ Price : $8.95]
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...