FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers - Sarepta Therapeutics (NASDAQ:SRPT)

FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers - Sarepta Therapeutics (NASDAQ:SRPT)

As gene therapies continue to evolve as a promising frontier in medical treatment, regulatory scrutiny intensifies following safety concerns. Recent developments with Sarepta Therapeutics Inc (NASDAQ:SRPT) highlight the delicate balance between innovation and patient safety in the biopharmaceutical industry. On Monday, the U.S. Food and Drug Administration (FDA) recommended lifting the voluntary hold on Sarepta’s gene therapy for Duchenne Muscul…

Shipments of Duchenne Gene Therapy to Resume After FDA Review of Patient Death

(MedPage Today) -- Drugmaker Sarepta Therapeutics said it would resume shipping its gene therapy for some patients, following a brief pause requested by regulators. The FDA said it recommended lifting the hold for young patients with Duchenne...

Sarepta jumps after FDA allows gene therapy for younger patients

Sarepta regained some of its losses from the month but is still down more than 80% for the year....

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta is facing intense scrutiny following the death of two non-ambulatory teenage boys associated with Elevidys.

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by safety concerns.

Post-Hoc: Is this what a political FDA looks like?

In the last two weeks, Sarepta has been asked by the FDA to pull its Duchenne gene therapy, refused to do so, capitulated, and then won a reversal. If the biotech industry was hoping that ...