News

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 stimulants to add weight loss risk in patients younger than 6
The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants to treat ...
FDA approves Benlysta autoinjector for pediatric patients with active lupus nephritis
The U.S. Food and Drug Administration has approved GSK's autoinjector of Benlysta (belimumab) for subcutaneous injection in ...
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Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
Chocolate Mousse Recall as FDA Issues Highest Risk Warning
Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.
Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma
Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug ...
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FDA Removes REMS, Reduces Monitoring Requirements For Breyanzi and Abecma
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
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New FDA guidance in the works for 2025
The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program ...
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FDA Eliminates REMS for CAR T-Cell Immunotherapies
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
FDA announces sweeping changes to speed up the drug review process
An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...
FDA to offer faster drug reviews to companies promoting 'national priorities'
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...
Unicycive Shares Slide Premarket as FDA Rejects Oxylanthanum Carbonate Application
Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response letter ...