entertainment -WSS

entertainment

author：Wikipedia 2025-09-07 04:13:52 - browse：514

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： In age of alternative facts, a scholarly course on calling out crap
Next article： A new study sees potential in DNA sequencing of infants

WSS

Elizabeth Holmes on track for early release from her 11

Why ADHD is under

Ahead of NATO summit, Biden meets with King Charles for 1st time since coronation

Study: Pain burden is higher in Black NFL players than white ones

Petition to FDA: Get the lead out of consumer hair dyes

What could happen if Russia blows up the Zaporizhzhia Nuclear Power Plant?

focus

entertainment

explore

Wildfire smoke exposes gaps in outdoor worker protections

Iowa House, Senate pass 6

Supreme Court strikes down use of affirmative action

Insurance companies sue energy corporation after it was blamed for helping start Colorado wildfire

DIEP, the 'gold standard' of breast reconstruction, is under threat

Trump seeks lengthy delay of classified docs trial, citing upcoming election

BioMarin wins approval for gene therapy to treat hemophilia A

Iowa House, Senate pass 6

Tori Bowie and the unacceptable rates of Black maternal death

Study: Pain burden is higher in Black NFL players than white ones

Wikipedia

Why ADHD is under

Drinking water from half of US faucets contains PFAS: Study

FDA approves Leqembi, a milestone in Alzheimer’s treatment

How the political right came to back psychedelics to treat trauma

Titanic submersible: What a 'catastrophic implosion' means and what officials found

California man arrested in connection with serial murders of Mexican strip club workers

leisure time

explore

explore

entertainment