News

FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis
Benlysta is the first and only approved autoinjector biologic for both systemic lupus erythematosus and lupus nephritis ...
US FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...
US FDA to revise label of ADHD medications to add weight loss risk in patients younger than 6
The U.S. Food and Drug Administration said on Monday that it is revising the labeling of all extended-release stimulants to ...
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies (June 27)
The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...
FDA requires updated warning about rare heart risk with COVID shots
U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...
FDA adds new warning to COVID vaccines: Here's why, info on 'razor blade throat' and more
As a new variant that causes 'razor blade throat' spreads, the FDA updates vaccine warnings to include information on heart ...
iTolerance, Inc. Appoints Former FDA Senior Executive Wayne Pines to the Board of Directors
MIAMI, FL / ACCESS Newswire / June 25, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held ...
FDA expanding COVID vaccine warnings over rare heart side effect
The U.S. Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include ...
Cookie Recall Update as FDA Warning Issued to Customers in 15 States
The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all ...
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FDA Approves First Treatment for Macrophage Activation Syndrome in Still Disease
Emapalumab is approved for both adults and pediatric (newborn and older) patients with MAS in Still disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
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FDA approves first-ever drug for macrophage activation syndrome in Still’s disease
The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...