entertainment -WSS

entertainment

author：leisure time 2025-09-27 15:19:40 - browse：4133

Sarepta - Cambridge -AP — A logo sign outside of the headquarters of Sarepta Therapeutics in Cambridge, Mass. Kristoffer Tripplaar/Sipa via AP

Reviewers at the Food and Drug Administration were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by Sarepta Therapeutics, prompting a top official to intervene earlier this year, according to three people with direct knowledge of the agency deliberations.

Inside the FDA office that oversees gene therapies, some staff had reached a non-binding conclusion that Sarepta’s gene therapy should be rejected, the individuals said, speaking on condition of anonymity. Peter Marks, a top FDA official and vocal advocate for faster gene therapy approvals, stepped in and directed staff to schedule a public hearing on the therapy on May 12.

Sarepta announced the scheduling of the public hearing last month, but the internal deliberations that led to it have not been previously reported.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED Log In

Previous article： Malaria cases in Florida and Texas: Here’s what you need to know
Next article： Oak Street deal isn't the answer to health care's woes

focus

WSS

The White House hikes tariffs on plastic syringes made in China

Bacterial infection may be ‘key event’ in endometriosis, study says

When is a doctor not a doctor? Try when patients address women doctors

Meta looks to target Twitter with a rival app called Threads

New case study details death in closely watched Alzhiemer's trial

Inside the fall of star MIT scientist David Sabatini

hotspot

entertainment

focus

As demand for Covid shots wanes, Moderna seeks its next success

4th of July breaks record for highest global temperature ever measured

United colonoscopy coverage change 'may cost lives,' doctors say

4 killed, 7 hurt in mass shooting at July 4 block party in Louisiana; no arrests made

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

Listen: PBM conflicts, RSV vaccines, & the future of flu season

United colonoscopy coverage change 'may cost lives,' doctors say

HHS suspends federal funding for EcoHealth Alliance

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Pfizer's Covid pill remains 89% effective in final analysis, company says

hotspot

WuXi Biologics beefs up its lobbying operation

7 people shot in DC, police say

Readout Newsletter: Biogen, Ionis, Johnson & Johnson news

Connecting traumatic brain injury and domestic violence

Brain 'hot spot' may explain why African Americans feel greater pain

Make 'food is medicine' a key part of White House nutrition meeting

entertainment

focus

hotspot

focus