Sandoz announced the European launch of its Pyzchiva (ustekinumab) autoinjector. This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung… read more.
GSK plc announced that the FDA has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s approval… read more.
Roche announced the introduction of its innovative Chest Pain Triage algorithm as part of the navify Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately… read more.
Merck Inc., (known as MSD outside of the United States and Canada), announced the FDA has accepted for priority review a supplemental new drug application (sNDA) seeking approval… read more.
Neurocrine Biosciences, Inc. announced the release of findings from a new survey conducted by The Harris Poll highlighting the profound negative impact of tardive dyskinesia on patients and… read more.
Celltrion announced that the FDA has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra. Avtozma is indicated for… read more.
Edwards Lifesciences announced new economic and clinical evidence on severe aortic stenosis (AS) presented as a late-breaking clinical trial at EuroPCR 2025, further contributing to the extensive body… read more.
The EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye disease…. read more.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Bosulif…. read more.
Johnson & Johnson announced new data from the Tremfya (guselkumab) Phase III QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). Data from the… read more.
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related… read more.
Alnylam Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending approval of its RNAi therapeutic… read more.
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