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.
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.
Medtronic plc announced the FDA approval for its Simplera continuous glucose monitor (CGM) — the company’s first disposable, all-in-one CGM that’s half the size of previous Medtronic CGMs…. read more.
Seres Therapeutics, Inc. announced that it signed an agreement with Société des Produits Nestlé S.A (“Nestlé”) for the sale of its Vowst business to Nestlé Health Science. Upon… read more.
Inspire Medical Systems, In a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the… read more.
ARS Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced… read more.
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