The FDA has given Sarepta Therapeutics the green light for its phase 2 Duchenne muscular dystrophy clinical trial after slapping the biotech with a clinical hold in June. The hold came after a grade 3 adverse event was reported in the midstage trial. Now, only a few months later, the agency has lifted the hold, and we'll discuss why there was a quick turnaround on the hold and what to expect next.
To learn more about topics in this episode:
- Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial
- As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy
- EU blocks Illumina's yearslong quest for Grail
- Philips recalls 17M CPAP and BiPAP machine masks due to potential magnet interference
- GSK helps SpringWorks double payday from boosted combo deal as it also reels $225M in new funding
- BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies
- Amylyx's ALS drug faces tough FDA scrutiny ahead of 2nd advisory panel meeting
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