Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the… read more.
Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA),… read more.
Jazz Pharmaceuticals plc announced top-line results from the Phase III open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex/Epidyolex globally)… read more.
Abbott announced that the FDA has approved a change to its label that will help patients who receive a HeartMate 3 left ventricular assist device (LVAD, or heart… read more.
Amneal Pharmaceuticals, Inc., announced that the FDA has approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel, oral formulation… read more.
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed… read more.
AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older… read more.
Galderma announced that the FDA has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. Nemluvio was granted Breakthrough… read more.
A new drug application (NDA) has been submitted to the FDA seeking the approval of mitomycin for intravesical solution (UGN 102) for the treatment of patients with low-grade,… read more.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive… read more.
Bavarian Nordic A/S has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the Imvanex (MVA-BN ) smallpox and mpox vaccine indication to… read more.
scPharmaceuticals Inc. announced that the FDA has approved its Supplemental New Drug Application (sNDA) seeking to expand the Furoscix indication for heart failure patients. At approval, Furoscix was… read more.
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