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Merck, Daiichi Sankyo Voluntarily Withdraw Biologics License Application Approval In U.S. For Ifinatamab Deruxtecan To Treat Small Cell Lung Cancer After Discussions With FDA

Sep 25, 2026 · 04:33 PM ET· updated 1h ago

The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan

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Why It Matters

Merck and its partner decided to pull back their new lung cancer medicine from FDA approval. When a company withdraws an application, it might mean they need more research or hit a roadblock.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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