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).
Novartis division Sandoz has secured marketing authorization from the European Commission (EC) for its biosimilar Hyrimoz (adalimumab) for use in all same indications as reference medicine including rheumatology, gastroenterology and dermatology.
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