Intera Oncology has recalled 440 Intera 3000 Hepatic Artery Infusion Pumps following three reports of potentially life-threatening medication flow rates. Although no injuries or deaths related […]
The US Food and Drug Administration (FDA) has approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor inhibitor, for adults with relapsed or refractory myeloid/lymphoid neoplasms […]
Medtronic is recalling 23,372 HeartWare HVAD System batteries due to the risk that they could unexpectedly fail, the US Food and Drug Administration (FDA) says in […]
The Food and Drug Administration (FDA) has approved use of the Omnipod 5 automated insulin delivery system (Insulet Corp) for children aged 2 years and older […]
The US Food and Drug Administration (FDA) has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of […]
The US Food and Drug Administration (FDA) has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in […]
Medtronic has recalled Cobalt XT, Cobalt, and Crome implantable cardioverter defibrillators (ICDs) and resynchronization therapy defibrillators (CRT-Ds) after reports that some devices delivered reduced-energy electric shocks, triggering […]
The US Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in […]
The US Food and Drug Administration today approved a supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in children aged 5 […]
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