ARS Pharmaceuticals, Inc. announced the European Commission’s approval of EURneffy for emergency treatment of severe allergic reactions in adults and children weighing at least 30 kilograms. This approval… read more.
GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic… read more.
Insulet Corporation , the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5)… read more.
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for the treatment of adult… read more.
Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse… read more.
UCB, a global biopharmaceutical company, announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets…. read more.
PROCEPT BioRobotics Corporation announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI treatment planning, advanced… read more.
Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the… read more.
Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA),… read more.
Jazz Pharmaceuticals plc announced top-line results from the Phase III open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex/Epidyolex globally)… read more.
Abbott announced that the FDA has approved a change to its label that will help patients who receive a HeartMate 3 left ventricular assist device (LVAD, or heart… read more.
Amneal Pharmaceuticals, Inc., announced that the FDA has approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel, oral formulation… read more.
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