european medicines agency news

European Committee Takes a Second Look at Alzheimer's Drug

Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved

Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.

The Associated Press - Busines… · 4d

European committee takes a second look at Alzheimer’s drug and now says it should be approved

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.

Medical Xpress · 4d

European watchdog partially approves new Alzheimer's drug

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.

FiercePharma4d

EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

health.economictimes.indiatimes12h

EU health agency urges stepped-up antibiotic resistance fight

The European Centre for Disease Prevention and Control (ECDC) said consumption of antibiotics in the EU had increased by one ...

emjreviews.com3d

EU Rejects Majority of US Fast-Tracked Cancer Drugs

A new study reveals that more than half of cancer drugs approved by the FDA under accelerated pathways are not authorized in ...

FiercePharma5d

EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...

Pharmabiz8h

European Union recommends approval of AstraZeneca’s Tagrisso for patients with unresectable EGFR-mutated lung cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA phase III trial, which were published in ...

Business Insider1d

CHMP Recommends Approval Of Lazcluze + Rybrevant In EU For EGFR-mutated Advanced NSCLC

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has ...

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