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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.
The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, they’ll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, they’re greeted with unfamiliar acronyms.
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This loan will further support the progress and expansion of OSE Immunotherapeutics' lead clinical development programs in diseases with high unmet medical .