Swissmedic has granted marketing authorization for Octapharma’s new fibrinogen concentrate product fibryga for the treatment of congenital and acquired fibrinogen deficiencies.
Spark Therapeutics and Novartis have secured the approval from the European Commission (EC) for their one-time gene therapy Luxturna (voretigene neparvovec) to treat patients with a rare inherited form of vision loss that could lead to blindness.
AbbVie and Roche have secured approval from the European Commission (EC) for the combination of Venclyxto (venetoclax) and MabThera (rituximab) to treat relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) in adult patients who had received at least one prior therapy.
Vertex Pharmaceuticals (Europe) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kalydeco (ivacaftor) to treat people with cystic fibrosis (CF) aged 12 to <24 months with certain mutations in the CFTR gene.
GlaxoSmithKline (GSK) and Innoviva secured positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the expanded use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol FF/UMEC/VI) in moderate to severe chronic obstructive pulmonary disease (COPD).
Mylan and Fujifilm Kyowa Kirin Biologics have secured marketing authorization from the European Commission (EC) for their Hulio, a biosimilar to AbbVie's Humira (adalimumab), for all indications.
The European Commission (EC) has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF), to treat bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or not indicated.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Alnylam Pharmaceuticals’ patisiran, an investigational RNAi therapeutic for the treatment of hATTR amyloidosis, a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
Novelion Therapeutics has secured marketing authorization from the European Commission (EC) for Myalepta (metreleptin) to treat generalized and partial lipodystrophy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinion for the approval of AstraZeneca’s Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not progressed after platinum-based chemotherapy and radiation therapy (CRT).
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