News

FDA approves Takeda’s Gammagard liquid ERC for primary immunodeficiency
The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune ...
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 ...
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 ...
San Francisco Examiner14h
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 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 ...
Food Safety News10h
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 ...
MPR16h
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 ...
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 ...
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 ...
STAT19h
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 ...