fbpx
August 30, 2022

Serious Recall of Intera Oncology’s Hepatic Artery Infusion Pump Serious Recall of Intera Oncology’s Hepatic Artery Infusion Pump

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 […]
August 26, 2022

FDA OKs First Targeted Agent, Pemigatinib, for Rare Blood Cancer FDA OKs First Targeted Agent, Pemigatinib, for Rare Blood Cancer

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 […]
August 25, 2022

Medtronic Recalls Additional Faulty HeartWare HVAD Batteries Medtronic Recalls Additional Faulty HeartWare HVAD Batteries

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 […]
August 24, 2022

FDA Clears Tubeless, Automated Insulin System for Kids 2 and Older FDA Clears Tubeless, Automated Insulin System for Kids 2 and Older

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 […]
August 23, 2022

FDA Clears New Neurostimulation System for Chronic Pain FDA Clears New Neurostimulation System for Chronic Pain

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 […]
August 22, 2022

FDA Approves ‘Rapid-Acting’ Oral Drug for Major Depression FDA Approves ‘Rapid-Acting’ Oral Drug for Major Depression

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 […]
August 19, 2022

Class I Recall of Medtronic Cobalt, Crome Cardiac Devices Class I Recall of Medtronic Cobalt, Crome Cardiac Devices

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 […]
August 17, 2022

FDA Approves Adalimumab Biosimilar in High-Concentration Form FDA Approves Adalimumab Biosimilar in High-Concentration Form

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 […]
August 12, 2022

Xofluza Approved for Treating Flu in Children Xofluza Approved for Treating Flu in Children

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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0