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.
Johnson & Johnson announced the FDA approval of a supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray, making this innovative treatment the first and only… read more.
GSK plc announced that the EMA has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the… read more.
Datroway (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC… read more.
Outlook Therapeutics, Inc., announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled… read more.
Galderma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing… read more.
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