Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to Imdylltra for the treatment of adult patients with extensive-stage… read more.
Axsome Therapeutics, Inc. announced that the FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo represents a novel… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) (UK) has 16 January 2025, approved the medicine seladelpar (Livdelzi) in adults for the treatment of a liver illness called… read more.
Valneva SE reported further positive Phase III data in adolescents for its single-shot chikungunya virus (Chikv) vaccine, Ixchiq, which showed a sustained 98.3% sero-response rate one-year after single… read more.
Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults… read more.
Supernus Pharmaceuticals, Inc .announced that the FDA has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The… read more.
Roche announced that the FDA has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with HR-positive, HER2-ultralow metastatic breast cancer… read more.
Bayer announced the submission of a marketing authorization application to the EMA, seeking approval in the EU for the use of finerenone in adult patients with HF with… read more.
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the… read more.
Novo Nordisk announced that the FDA has approved Ozempic (semaglutide injection) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to… read more.
Biogen Inc. announced that the FDA has accepted the company’s supplemental New Drug Application (sNDA) and the EMA has validated the application for a higher dose regimen of… read more.
Neurocrine Biosciences, Inc. announced publication of a classic congenital adrenal hyperplasia (CAH)-focused supplement in The Journal of Clinical Endocrinology & Metabolism (JCEM), sponsored by the company. The supplement,… read more.
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