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 ...
San Francisco Examiner3h
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 ...
Food Safety News19h
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 ...
Food and Drug Administration staff cuts may hinder US biomedical innovation
The elimination of 3,500 full-time employees at the FDA risks undermining the very innovation and domestic capacity the ...
MPR6h
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 News10h
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.
How we plan to cut FDA drug approval time by months
Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...
STAT8h
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.
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 ...