Marching On: Eight Novel Agents Among March Goal Dates For US FDA

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

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MARCH IS COMING IN • Source: Shutterstock

The month of March will bring eight more chances for the US FDA to approve novel drugs and biologics, potentially providing a corrective to 2024’s slow start for innovative approvals.

The number of user fee goal dates for novel agents on the FDA’s March calendar already outweighs the new molecular entity and novel biologic decisions in January and February combined, the Pink Sheet’s US FDA Performance Tracker

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