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 Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...
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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 ...
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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 ...
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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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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Neurizon Therapeutics receives positive opinion on orphan medicinal product designation for NUZ-001 in Europe
Neurizon Therapeutics Limited (Neurizon), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, announced it has received notice of a positive opinion from the ...
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 ...