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 ...
AFP on MSN1h
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 ...
STAT2h
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 ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
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 ...
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myelomaRecommendation based on IMROZ ...
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with ...
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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 ...
NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury, Accelerating Pathway to European Markets
NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (" NurExone " or the " Company "), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce ...
NurExone Biologic Inc: NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury, Accelerating Pathway to European Markets
NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) ("NurExone" or the "Company"), a biopharmaceutical company developing exosome-based ...
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with ...
Morningstar8d
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.