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Seven PDUFA dates on FDA’s November calendar

Upcoming decisions include BridgeBio’s ATTR cardiomyopathy drug, PTC’s gene therapy, and Autolus’ CD19 CAR T

October 31, 2024 12:18 AM UTC

Among the seven disclosed PDUFA dates coming up in November is a decision that could see BridgeBio enter the market for TTR amyloidosis with cardiomyopathy ahead of Alnylam.

BridgeBio Pharma Inc. (NASDAQ:BBIO) is expecting a decision by the end of the month on its application for acoramidis, a small molecule TTR stabilizer, to treat ATTR with cardiomyopathy (ATTR-CM)...