2024 First Generic Drug Approvals
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As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions.Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.Bornstein Seafoods Inc Recalls Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat Because of Possible Health Risk
June 10, 2025, Bornstein Seafoods of Bellingham, Washington is recalling 44,550 Lbs. of Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat (see table below for multiple lot codes) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and somExpanded Access to Investigational Drugs for Treatment Use – Questions and Answers – 04/15/2026
An informative webinar on the FDA guidance Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
