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.
The FDA has granted priority review to asciminib (Scemblix) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase (CP-CML)…. read more.
UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and… read more.
Atrial fibrillation (Afib) is the most common heart rhythm disorder encountered in clinical practice according to Dr. Roopinder Sandhu, MD, MPH, and the leading cause of stroke in… read more.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a review of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment… read more.
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