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accelerated approval
Biotech
Regenxbio starts pivotal study for DMD gene therapy
Regenxbio’s gene therapy improved muscle function for patients with DMD in a phase 1/2 study, with the biotech rolling the trial into a pivotal study.
Gabrielle Masson
Nov 18, 2024 2:24pm
Wave surfs DMD success to regulators' doors, sending stock up
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
