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 ...
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.
Nippon5d
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 ...
STAT5d
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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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 ...
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, ...
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 ...
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 ...
BioPharma Dive5d
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.
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European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, ...
The Australian9d
NUZ inks positive opinion on orphan product designation for NUZ-001 in Europe
Notice of positive opinion from EMA NUZ has received notice of a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) following its application ...