Tag: FDA
Second patient death reported with gene therapy for muscular dystrophy, ET HealthWorld
Washington: Shares of Sarepta Therapeutics plunged Monday after the biotech drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. Sarepta reported the death over the weekend and provided additional details about its response, which includes pausing shipments of the therapy, Elevidys, for older patients who are no longer able to…
The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we’re living in a time of widespread disinformation and pushbacks against science, but why not rush things through with AI? Elsa — yes, weirdly like the snow queen from Frozen — completed a…