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THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.
The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.
AstraZeneca s Farxiga gets Priority Review status in the US ifamagazine.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from ifamagazine.com Daily Mail and Mail on Sunday newspapers.
LONDON (dpa-AFX) - AstraZeneca Plc. (AZN.L, AZN) said Wednesday that its Farxiga has been granted priority review in the US for the treatment of new or worsening chronic kidney disease in adults