A comprehensive view of FDA Drug / Device Reviews. This page highlights a small sample of our full coverage.
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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
Published:
April 16, 2024
by GSK Group (GlaxoSmithKline)
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Novartis halts registration of new breast cancer patients for Kisqali clinical trials due to recent FDA guidelines lowering nitrosamine content in drugs; Novartis plans to align manufacturing with new regulations by Q2 end
Published:
April 10, 2024
by FiercePharma
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Bristol Myers' Krazati and Eli Lilly's Erbitux show efficacy in Phase 1/2 trial for a rare form of colorectal cancer driven by KRAS G12C gene mutation; FDA expected to make a decision on treatment by June 2024
Published:
April 09, 2024
by SeeNews Pharmaceuticals
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FDA accepts Purdue Pharma's application for its nalmefene hydrochloride auto-injector opioid overdose treatment, with a priority review status; goal date for decision set for August 7, 2024
Published:
April 08, 2024
by Business Wire
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FDA instructs Eisai and Biogen to seek Fast Track designation for Alzheimer drug lecanemab's subcutaneous formulation, impacting regulatory submission plans and causing potential delays; decision expected within 60 days of March 2024 submission
Published:
April 05, 2024
by Psychiatric Times
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