FDA Update: Keytruda and Aduhelm News Leads the Week
July 10th 2021Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.
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FDA Roundup: Pediatric Indications, More in Alzheimer's Pipeline?
June 26th 2021Regulatory actions for drugs for children, a combination cancer therapy, launches of two generic therapies for COPD, and cancer and Alzheimer’s therapies receive Breakthrough Designation round out this week’s FDA news.
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