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 ...
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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 ...
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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 ...
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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 The ...
EU health agency urges stepped-up antibiotic resistance fight
The European Union health agency on Monday warned that Europe was set to miss goals on reducing the use of antibiotics, ...
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European Agency Switches to Recommending New Alzheimer's Drug
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...
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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 ...
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 ...
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 ...
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Eisai wins over European regulators on Alzheimer’s drug Leqembi
The EMA sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
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 ...