Surgical mesh for transvaginal repair to be taken off the market
Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product after an order from the Food and Drug Administration.
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ALIVECOR: FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias
BOSTON SCIENTIFIC CORPORATION: Receives FDA Approval for LOTUS Edge™ Aortic Valve System
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
Out-of-pocket drug costs a key voter concern, new poll finds
Lowering out-of-pocket costs for prescription drugs is among American voters’ top health concerns, a new poll by released by a drug company trade association concludes.
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ABBVIE: Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for pediatric patients with lupus
The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.
'Stop doing these analyses,' Mercatus Center researcher says ahead of FDA benefit-risk public meeting
The U.S. Food and Drug administration's public meeting in May about the agency's human drug lifecycle benefit-risk activities has already attracted a recommendation from a regulatory and policy researcher: “stop doing these analyses.”