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.
Octapharma USA, Inc. has announced the expanded approval of fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by… read more.
Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has launched its TriLEAP Lower Extremity Anatomic Plating System, a comprehensive system with… read more.
Pacira BioSciences, Inc announced that the U.S. District Court for the District of New Jersey has found that the company’s U.S. Patent No. 11,033,495 (the ‘495 patent) is… read more.
Pfizer Inc. announced positive top-line safety and immunogenicity results from sub-study B of the ongoing pivotal Phase III clinical trial ( NCT05842967 ) MONeT (RSV I Mmunizati ONStudy… read more.
Novartis announced that the FDA has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy… read more.
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