News

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 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 ...
The Manila Times4h
Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure
Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items ...
Stocktwits on MSN1h
FDA Flags Weight Loss Risk In ADHD Meds For Kids — J&J, Novartis Escape New Warning
U.S health officials are updating the prescribing labels of long-acting ADHD medications to carry new warnings for children ...
STAT13h
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.
MPR11h
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.
Food Safety News1d
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 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 ...
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...
Renal & Urology News15h
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.
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 ...
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 ...