BAYRY PDUFA Date: Sevabertinib Page updated September 15, 2026 · next FDA decision on the calendar · Data as of Oct 11, 2026 9:31 PM ET FDA decision Approved September 9, 2026 · Bayer · HER2-mutant NSCLC, 1L (sBLA, Priority Review)
Key facts FDA decision Approved September 9, 2026
Drug / candidate Sevabertinib
Indication HER2-mutant NSCLC, 1L (sBLA, Priority Review)
Company Bayer
Market-cap tier Large
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See the full 2026 PDUFA calendar → FAQ What did the FDA decide on BAYRY's Sevabertinib? The FDA decided BAYRY's (Bayer) application for Sevabertinib on September 9, 2026: Approved. We do not state a goal date for this application: the date we had carried was never sourced to a filing or company release. Verify against the linked primary source.
What is BAYRY's drug Sevabertinib? Sevabertinib is Bayer's drug, approved by the FDA on September 9, 2026 for HER2-mutant NSCLC, 1L (sBLA, Priority Review).
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