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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 ...
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 ...
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.
MPR17h
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.
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 ...
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 ...
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 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 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 ...