Merck Recasts Keytruda Regulatory Strategy In Head & Neck Cancer To Capitalize On KEYNOTE-048
Withdrawal of sBLA for full approval of Keytruda in second-line SCCHN makes way for Merck to file for first-line use.
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker, including a PMA supplement for Agilent’s PD-L1 IHC 22C3 pharmDx companion diagnostic for Merck’s Keytruda (pembrolizumab), an anti-PD-1 drug, for patients with head and neck squamous cell carcinoma. The US FDA also approved a supplement for the Cochlear Nucleus Profile Plus Series Cochlear Implant, designed to be safe with magnetic resonance imaging.
The latest drug development news and highlights from our US FDA Performance Tracker.
User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.