FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

The FDA removes a long-standing warning from hormone-based menopause drugs

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause ...

Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter(TM) Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

Arctx Medical, Inc. ("Arctx, " "the Company"), a clinical-stage medical device company, announced today that it has achieved two additional significant milestones: Arctx was granted FDA 510(k) ...

Longtime FDA oncology leader named agency’s top drug regulator

The US Food and Drug Administration said Tuesday that Dr. Richard Pazdur has been named head of the Center for Drug Evaluation and Research, its largest division, which oversees the safety and ...
Oklahoma's News

FDA warns websites selling unapproved Botox for cosmetic purposes

Associated Press (AP) — U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth ...
KHON2

FDA restricts use of kids’ fluoride supplements citing emerging health risks

WASHINGTON (AP) — The Food and Drug Administration on Friday moved to limit the use of fluoride supplements used to strengthen children’s teeth, the latest action by Health Secretary Robert F. Kennedy ...