Eisai Co., Ltd. announced that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered… read more.
Viridian Therapeutics, Inc. announced that the FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disease characterized by… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Imvanex,… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Leqvio… read more.
Bavarian Nordic A/S announced that Health Canada has approved Vimkunya (recombinant, adsorbed) for immunization to prevent disease caused by chikungunya virus infection for individuals 12 years of age… read more.
Shionogi announced that it has received supplemental approval in Japan for the pediatric dosage and administration of XOCOVA (generic name: ensitrelvir fumaric acid; hereinafter “XOCOVA”), an anti-SARS-CoV-2 drug,… read more.
AbbVie announced that the EC has approved SKYRIZI (risankizumab) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis… read more.
Novo Nordisk Pharma Co., Ltd. (Japan) announced an adaptation to the existing approval for its long-acting human growth hormone analog formulation “Sogrua” (generic name: Somapsitan (genetically modified)). The… read more.
Gilead Sciences announced that the EC has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast… read more.
Novocure announced topline results from its Phase 3 TRIDENT trial, which evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) at the start… read more.
Arrowhead Pharmaceuticals, Inc. announced that the European Commission (EC) has formally granted marketing authorization for Redemplo (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet… read more.
The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of… read more.
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