european medicines agency news

European Committee Takes a Second Look at Alzheimer's Drug

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.

STAT · 1d

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.

Medical Xpress · 1d

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.

20h

Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...

11hon MSN

European Vaccine Makers Under Pressure After Trump Picks RFK Jr to Lead Health Department

Shares in European vaccine makers tumbled after President-elect Donald Trump picked vaccine sceptic Robert F. Kennedy Jr. to ...

11d

European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

ndtvprofit3d

Aurobindo Pharma Subsidiary Receives GMP From European Medicines Agency For Biosimilars Facility

CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...

Benzinga.com28d

European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer

The European Commission (EC) will decide in approximately two months. Last month, Novartis released new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab ...

14h

Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio

MEDIA RELEASEAfqlir® (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD)One ...

FiercePharma7h

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.

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European Committee Takes a Second Look at Alzheimer's Drug

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