1. Pink Sheet

Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

 
• By Derrick Gingery

US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.

FDA commissioner Scott Gottlieb

Merck & Co. Inc.'s new molecularly-targeted indication for Keytruda could help open the door to orphan incentives for such products.

US FDA Commissioner Scott Gottlieb said discussions are ongoing inside the agency about whether an indication based on a genetic...

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