Merck announced the FDA has accepted for priority review a new supplemental biologics license application, or sBLA, seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Ac, or PDUFA, or target action, date of September 25.
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