A comprehensive view of FDA Drug / Device Reviews. This page highlights a small sample of our full coverage.
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Recent Articles

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US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab-gxly) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer

FDA approves Roche's oral Alecensa for ALK-positive early-stage lung cancer treatment following successful Phase 3 trial; trial results show Alecensa reduced the risk of disease recurrence or death by 76%

FDA grants fast track designation to Asklepios BioPharmaceutical's AB-1002, a gene therapy for adults with non-ischemic cardiomyopathy and Class III heart failure symptoms; the therapy is currently in Phase 2 trials

IceCure Medical submits final data to the FDA for market authorization for the ProSense cryoablation system to treat early-stage T1 invasive breast cancer; the system treats tumors by freezing them with liquid nitrogen

GSK's 5-in-1 meningococcal ABCWY vaccine candidate accepted for review by the FDA; vaccine aims to provide broad protection against the five most common bacterial groups that cause invasive meningococcal disease

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