comprehensive -WSS

comprehensive

author：entertainment 2025-10-01 17:34:25 - browse：437

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： FDA approval of Sarepta Duchenne genetic therapy gives me hope
Next article： Roche's accidental data boosts hopes for anti

focus

WSS

Fentanyl is making it harder to start addiction treatment

Readout Newsletter: Eli Lilly, AstraZeneca, Bristol Meyers Squibb

Readout Newsletter: H5N1 bird flu vaccine, Cytokinetics, Gilead

Meadows told special counsel he could not recall Trump ever declassifying Mar

DeSantis wants to import drugs. Biden’s FDA blasted his plan

Health officials lay out plans to cope with respiratory virus season

focus

comprehensive

hotspot

Sports medicine is finally prioritizing gender equality

Abortion policy in the spotlight at Republican debate

New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

Wegovy improves function in certain heart failure patients

BioMarin wins approval for gene therapy to treat hemophilia A

Trans patients at the end of life deserve respect and dignity

As demand for Covid shots wanes, Moderna seeks its next success

The Readout: Biogen, Guardant, AstraZeneca, H5N1 vaccine

Trump demands the U.S. pay no more for drugs than other countries … again

As obesity drug market grows, telehealth companies court payers

hotspot

As obesity drug market grows, telehealth companies court payers

Readout Newsletter: H5N1 bird flu vaccine, Cytokinetics, Gilead

Meadows told special counsel he could not recall Trump ever declassifying Mar

DeSantis wants to import drugs. Biden’s FDA blasted his plan

Making the case for fair compensation in clinical trials

Liver decline slowed by off

explore

focus

leisure time

Wikipedia