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 ...
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
DPA International on MSN8h
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
AFP on MSN11h
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 ...
STAT12h
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 ...
Nippon23m
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 ...
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 ...
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 ...
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
ndtvprofit2d
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 ...
Morningstar9d
Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Designation (RPD) from the FDA, and ODD from the European Medicines Agency (EMA) for the treatment of SCN2A-DEE and SCN8A-DEE.