comprehensive -WSS

comprehensive

author：explore 2025-09-29 01:36:04 - browse：288

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： Alkermes shareholders re
Next article： Orchard's therapy for neuron disease in children wins FDA approval

WSS

Readout Newsletter: Geron, Novo Nordisk, WuXi updates

Methadone treatment changes are coming. Do they go far enough?

Intarcia’s device

Plastic surgeons increase patient psychiatric screenings

Second xenotransplant done with gene

Biotech lab space demand falls sharply

explore

comprehensive

hotspot

Cancer drug shortages should be causing more outrage

SCOTUS questions limit to govt efforts to fight misinformation

In Memoriam: Notable people who died in 2023

Virtual Event: March of the Biosimilars

At least 13 dead in Texas as scorching temps continue

Hearing on Medicare drug price negotiation gets unusually heated

Guidelines to prevent youth baseball injuries need more muscle

Nurses recount patients attacks

Hollywood unions extend contract negotiations for actors

Biotech stock slump in 2023: awaiting the turnaround

hotspot

Lasker Awards 2023: Winners in biomedical research

Gene editing the human germline: What are the risks?

It's been 20 years since Dolly the sheep. Where's my clone?

Stop the failed accountable care organization experiment

Medical student insurance fails on mental health care coverage

Thermo Fisher plant for manufacturing gene therapies to expand

explore

explore

hotspot

knowledge