Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of… read more.
Novo Nordisk announced that the FDA has issued a Complete Response Letter covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus…. read more.
Idorsia Ltd announced that the European Commission (EC) has approved Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive… read more.
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils…. read more.
Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis… read more.
A new observational study reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision… read more.
Roche announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to… read more.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic… read more.
Biocon Biologics Ltd (BBL),announced that the FDA has approved the Company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor… read more.
Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted… read more.
The FDA approved Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which… read more.
Johnson & Johnson announced that the FDA has issued traditional approval for Sirturo (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older… read more.
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