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accelerated approval
Biotech
Wave surfs DMD success to regulators' doors, sending stock up
Wave has met its goal in a Duchenne muscular dystrophy study, positioning it to talk to regulators about accelerated approval.
Nick Paul Taylor
Sep 24, 2024 9:51am
Ultragenyx gets green light to seek FDA approval of gene therapy
Jun 13, 2024 5:55am
How Peter Marks plans to prevent '3 billion visits' to FDA
May 8, 2024 11:05am
FDA's Richard Pazdur explains confirmatory trial rejection, more
Apr 8, 2024 6:00am
Sarepta's next DMD drug seems to get the job done in phase 2
Jan 29, 2024 10:49am
Amgen's tarlatamab BiTEs at SCLC in brief readout
Aug 3, 2023 4:01pm