entertainment -WSS

entertainment

author：hotspot 2025-10-01 23:58:20 - browse：77361

FDA's Peter Marks talks with STAT's Adam Feuerstein — Peter Marks, the FDA's top regulator of gene therapies (right), speaks with STAT's Adam Feuerstein in San Francisco. Sarah Gonzalez/Peopletography for STAT

SAN FRANCISCO — Peter Marks, the Food and Drug Administration’s top regulator of gene therapies, seems very comfortable with granting some form of full approval to Elevidys, the Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy, based on his comments to me on Monday night during our “fireside chat” at a STAT event.

To be clear, Marks declined to comment specifically about the ongoing FDA review of Elevidys. I tried. However, Marks described a “hypothetical case” in the context of my Sarepta questions that clearly suggested the failure of an Elevidys confirmatory study in October didn’t bother him all that much.

“Hypothetically, if you had a product that used an aggregate scale and all of the components of that aggregate scale looked pretty good, or nearly all of them look pretty good, but the aggregate, for various reasons, didn’t come out perfectly. We approved products based on that,” Marks told me.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Supreme Court strikes down use of affirmative action
Next article： Sutter Health’s antitrust win overturned by appeals court

WSS

Congress needs to close a vaccine

Why Eli Lilly’s earnings didn’t quite live up to the hype

BD to buy Edwards patient monitoring unit for $4.2 billion

Elevance PBM president out as customers face prescription chaos

Too many hospitalized Covid

Data don't support strong claims for Covid

focus

entertainment

focus

State Dept. review finds Biden bears some blame for Afghanistan failures

Stopping antidepressants leads to symptoms for 1 in 6 patients

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

'Little Tech' descents on D.C., wanting a say in how AI is regulated

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

Sutter Health’s antitrust win overturned by appeals court

Apple is now the first public company to be valued at $3 trillion

For pregnant people, addiction treatment shouldn't mean a call to child protective services

Peter Hotez and the public health issue of online harassment

Tome Biosciences co

focus

Study gives hint on South Asians’ higher risk of cardiovascular disease

Long Covid research funding gets a major boost from NIH

Sutter Health’s antitrust win overturned by appeals court

Abbott's new heart device gets FDA advisory panel nod

Stopping antidepressants leads to symptoms for 1 in 6 patients

Report cites 'urgent' need to recruit more diverse clinical trial participants

leisure time

explore

Wikipedia

entertainment