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Biohaven’s Taldefgrobep Alfa Receives FDA Fast Track Designation

Has potential to be a novel therapy used in combination with disease modifying therapies to enhance muscle function by blocking myostatin activity.

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 taldefgrobe...

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