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DATA GRAPHICS | Data Byte

Thirteen PDUFA dates coming up in October

Highlights include decisions on Pfizer’s ulcerative colitis candidate etrasimod and Alnylam’s Onpattro for ATTR-CM

September 29, 2023 11:29 PM UTC

FDA has at least 13 target action dates on its October roster, including a new treatment for ulcerative colitis that could be best in its target class, and extension of Alnylam’s Onpattro to treat ATTR-CM.

While  Pfizer Inc. (NYSE:PFE) has not disclosed an exact PDUFA date for etrasimod, its S1PR1 inhibitor under review to treat ulcerative colitis, FDA’s target date is likely in October given when the agency accepted the application for review.  ...

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