Wikipedia -WSS

Wikipedia

author：explore 2025-09-06 01:59:17 - browse：2

Amylyx founders — Justin Klee, left, and Joshua Cohen, both co-founders and co-CEO's of Amylyx Pharmaceuticals. Kayana Szymczak for STAT

The Food and Drug Administration has reversed an internal decision and will now review an experimental treatment for amyotrophic lateral sclerosis — a victory for ALS patients and advocates who have been pressuring regulators to act with more urgency against the fatal, neurodegenerative disease.

Amylyx Pharmaceuticals, a Cambridge, Mass.-based drug maker, said Wednesday that it will submit an application for its ALS treatment, called AMX0035, “in the coming months.”

The filing will be based largely on a single clinical trial of AMX0035 completed one year ago that showed a significant slowing of disease progression in patients with ALS. It’s the same study that FDA officials told Amylyx last April was encouraging, but not convincing enough to review for approval on its own. The company was told by FDA staff to conduct another study, gather more positive data, and then file for approval.

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

Subscribe Log In

Previous article： Wildfire smoke exposes gaps in outdoor worker protections
Next article： Readout LOUD podcast: brain research, obesity drug sales, Novartis

WSS

Elevance, private equity launch primary care company

FAMU bans football players from facility after release of rap video shot in team's locker room

Steward Health Care files for bankruptcy

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

FDA approves first blood sugar monitor without finger pricks

Weekend shootings leave at least 6 dead, 20 others wounded in Chicago

hotspot

Wikipedia

knowledge

Medicare proposal to cover medical devices draws a mixed reaction

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

Affirmative action in medical school literally saved lives

4 missing after record

In Memoriam: Notable people who died in 2023

Elevance, private equity launch primary care company

Cancer drug shortages should be causing more outrage

Woman found dead after suspected bear encounter near Yellowstone, wildlife officials say

Duchenne breakthrough therapy leaves behind pioneering families

Malaysia cuts short music fest after British band slams anti

explore

FAMU bans football players from facility after release of rap video shot in team's locker room

Software glitch causes Tandem insulin pump to shutdown, FDA warns

Study: Adult vaccinations pay for themselves in societal benefits

Use wet bulb globe temperature, not heat index, to protect workers

How to improve immunocompromised access to mAb treatments

What Henrietta Lacks's story taught me about my role as a doctor

explore

leisure time

focus

entertainment