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marketing authorisation application (MAA)

A gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-Thalassemia (TDT) is granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read more

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Specialty pharmaceutical company, Alliance Pharma, has revealed that following discussions with the MHRA and the CHM, the marketing authorisation application for Diclectin is now considered approvable. Read more

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The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA). Read more

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Shire has announced that the European Medicines Agency (EMA) has validated its marketing authorisation application (MAA) for lanadelumab (SHP643) for investigational Hereditary Angioedema (HAE) treatment. Read more

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The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) of a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia from Cinfa Biotech. Read more

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Global biotechnology company, Shire, has submitted a marketing authorisation application (MAA) for its dry eye treatment, liftegrast, which, if approved, would represent the first and only LFA-1 antagonist drug to treat the disease in Europe. Read more

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Global research and development-based pharmaceutical company, Eisai, has submitted a marketing authorization application to the European Medicines Agency (EMA) for its first-line hepatocellular carcinoma treatment, lenvatinib. Read more

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The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab) from Sandoz Read more

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Biopharmaceutical company, TiGenix, has submitted responses to the marketing authorisation application for Cx601, a treatment of complex perianal fistulas in Crohn’s disease patients as a first indication. Read more

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Kiadis Pharma, a clinical stage biopharmaceutical company, has submitted a marketing authorisation application (MAA) to the EMA for its lead product ATIR101 Read more

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Helsinn’s anamorelin HCI has been accepted for marketing authorisation application (MAA) review by the European Medicines Agency (EMA) Read more

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