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Biohaven’s Taldefgrobep Alfa receives FDA Fast Track Designation

February 21, 2023


Biohaven Ltd. has been granted fast track designation from the U.S. FDA for taldefgrobep alfa, a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy (SMA).

Fast Track designation allows important new drugs to reach patients earlier by facilitating more frequent communications with the FDA and expeditious review of a drug which treats a serious condition and fills an unmet medical need.

Biohaven previously received orphan drug designation from the FDA for taldefgrobep in the treatment of SMA.

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