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Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer

Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer

Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers. Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death […]

Pfizer lung cancer drug Vizimpro bags CHMP’s positive opinion

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Pfizer lung cancer drug Vizimpro (dacomitinib) 45 mg in Europe as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The positive opinion adopted by the European Medicines Agency (EMA) committee is […]

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Spark Therapeutics bags Luxturna EU approval for inherited retinal disease

Luxturna EU approval for inherited retinal disease : Pennsylvania-based Spark Therapeutics has bagged the European Commission’s (EC) approval for its gene therapy Luxturna (voretigene neparvovec) to treat a rare inherited type of vision loss in both children and adults. Luxturna EU approval for inherited retinal disease Luxturna, an adeno-associated viral (AAV) vector gene therapy has […]

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Hyrimoz EC approval : Novartis biosimilar of AbbVie Humira approved in EU

Hyrimoz EC approval : Novartis’ Sandoz has bagged approval for Hyrimoz (adalimumab), a biosimilar of AbbVie’s Humira (adalimumab), in Europe for all indications of the reference drug including rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis and ulcerative colitis. The approval of Hyrimoz by European Commission (EC) was driven by analytical, preclinical and clinical research that […]

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CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

Update on Imfinzi EMA approval : The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca lung cancer drug Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The committee has recommended Imfinzi EMA approval of […]

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