focus -WSS

focus

author：comprehensive 2025-09-30 17:45:48 - browse：34253

European Medicines Agency Suffers Cyber Attack in Amsterdam — Paulo Amorim / VWPics via AP Images

LONDON — This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment — the latest potential turning point for a drug that has seen its share of ups and downs with regulatory bodies.

In June, a European Medicines Agency committee issued a negative review of Amylyx’s drug, called Albrioza, and cast doubt on whether it had demonstrated effectiveness in its pivotal study. That would have almost certainly led to a rejection by regulators, but Amylyx requested what’s called a re-examination of the opinion. On Tuesday, the EMA held a meeting on the appeal, and a decision is expected in the coming weeks.

“There are patients who are dying and they really want access to the drug,” said Evy Reviers, the chairwoman of the European Organization for Professionals and Patients with ALS, whose father has the neurological disease.

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

Subscribe Log In

Previous article： Bright Health sells Medicare Advantage business to Molina
Next article： National associations that represent hospice owe an apology

WSS

Readout Newsletter: The latest on Novo Nordisk, Alnylam, Apogee

Lack of health data on LGBTQ+ people has serious consequences

Longer MASH drug regimen improved liver, Akero study finds

Harvard's David Sinclair gets blowback over aging

The public health thinking behind the CDC’s new Covid guidance

Study: Spinal cord stimulation helps patients with paralysis walk again

entertainment

focus

focus

After affirmative action ruling, medical educators look to 'holistic review'

People can get long Covid without testing positive for virus: Study

Peter Hotez and the public health issue of online harassment

The untold story of TV’s first prescription drug ad

Medical leaders decry Supreme Court decision on affirmative action

California store owner shot dead in dispute over displaying Pride flag: Police

ChatGPT in medicine: STAT answers readers' burning questions

CDC says it’s too soon to assess risk posed by Covid subvariant

After affirmative action ruling, medical educators look to 'holistic review'

Republicans love RFK Jr. What's that tell us about health in 2024?

focus

Why Talkspace is targeting Medicare, a tricky market

As obesity drug market grows, telehealth companies court payers

IVF doctors demand details after CooperSurgical lawsuit

The public health thinking behind the CDC’s new Covid guidance

Change Healthcare: What is it, why does its cyberattack matter?

Former Pear Therapeutics executives start new VC firm

explore

hotspot

explore

knowledge