Aumseqa
Stories
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EMA recommends approval of seven new medicines at CHMP meeting
The Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Aumseqa, Baxfendy, Zybrivo, Garzulys, Donrafylix, Fondaparinux sodium Evumed, and Ruxolitinib Krka. The recommendations cover treatments for non-small cell lung cancer, hypertension, non-squamous non-small cell lung cancer, diabetes, venous thromboembolism, and myelofibrosis, among others.
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CHMP adopts positive opinion on Aumseqa
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a marketing authorization for Aumseqa, a 55 mg film-coated tablet intended for first-line treatment of adult patients with advanced NSCLC harbouring EGFR exon 19 deletions or L858R mutations, and for treatment of EGFR T790M mutation-positive NSCLC. The applicant for the medicinal product is SFL Pharmaceuticals Deutschland GmbH.