Johnson & Johnson announced a new analysis of Phase III data which found Caplyta (lumateperone), in combination with an antidepressant, showed significantly greater remission rates in adults with… read more.
Soleno Therapeutics Inc. announced a publication in the peer-reviewed Journal of Clinical Endocrinology and Metabolism (JCEM). The paper, titled, “Diazoxide Choline Extended-Release Tablets in Prader-Willi Syndrome: A Randomized,… read more.
NICE (UK) is unable to make a recommendation on concizumab (Alhemo) for treating haemophilia A or B in people 12 years and over with factor inhibitors. This is… read more.
Edwards Lifesciences announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive FDA approval for the treatment of… read more.
Telix Pharmaceuticals Limited announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for… read more.
GSK plc announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment… read more.
Agios Pharmaceuticals, Inc. announced that the FDA has approved Aqvesme (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia…. read more.
Nxera Pharma Co., Ltd. announces that positive top-line results were obtained from a Phase III study conducted in South Korea evaluating daridorexant 50 mg in adult and elderly… read more.
Abbott announced it has received CE Mark in Europe for the TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with atrial fibrillation (AFib). Following the new approval,… read more.
Camurus announced that the FDA has accepted for review the company’s resubmission of the New Drug Application (NDA) for Oclaiz (CAM 2029), octreotide extended-release injection, for the treatment… read more.
The European Commission has granted marketing authorization in the European Union (EU) for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of… read more.
The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and… read more.
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