fashion -WSS

fashion

author：explore 2025-10-01 11:46:12 - browse：91816

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： Affirmative action in medical school literally saved lives
Next article： Idaho college killings prosecutors challenge defense's grand jury claims

Wikipedia

hotspot

WSS

Health AI: on the border between health care and tech

How to protect coverage of PrEP

Burning questions about Delta and the next phase of the Covid pandemic

Thousands protest mob assault of women who were paraded naked in remote Indian border state

Treatments for cramps don't cut it. Why aren't there better options?

Health AI: on the border between health care and tech

knowledge

fashion

entertainment

Hepatitis C has a cure — but many Americans still lack access to it

4 missing after record

The high cost of giving birth even with insurance

Hospitals are dialing back on venture capital investing

Psychedelics group wrestles with new pharma identity

Charges dismissed against white woman who spat on Black woman during protests in Connecticut

Psychedelics group wrestles with new pharma identity

Transgender women dream of pregnancy via uterus transplants

Moonlake's readout produced a cash windfall. Risks remain

Schizophrenia gene found to be linked to cells' energy dysfunction

focus

How to protect coverage of PrEP

Mike Pence ‘not interested in trading insults’ with Trump as he tries to win New Hampshire

Burning questions about Delta and the next phase of the Covid pandemic

Severe heat forecast: Where scorching temperatures will persist over the next week

Health AI: on the border between health care and tech

Yogurt drink instead of a colonoscopy? CRISPR bacteria are tested

Wikipedia

hotspot

focus

focus