News

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 ...
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 ...
STAT5h
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.
San Francisco Examiner48m
With FDA nod, cell-grown salmon headed for an SF restaurant
San Francisco-based Wildtype, a startup that is pioneering cell-grown salmon, cleared a U.S. Food and Drug Administration ...
MPR9h
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.
MPR3h
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.
Renal & Urology News7h
FDA Approves Harliku for Patients With Alkaptonuria
The Food and Drug Administration has approved Harliku (nitisinone) for the reduction of urine homogentisic acid in adult patients with alkaptonuria.
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 ...
Food Safety News16h
FDA issues warning letters about botulism risk in canned desserts and illegal drug claims in supplements
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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 ...
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 ...