Infant botulism cases tied to ByHeart formula rise to 31 across 15 states

The FDA says eight more infants have been hospitalized in the outbreak, warning that recalled ByHeart formula is still ...

Cases jump to 31 in the botulism outbreak tied to baby formula. Here's what to know

Federal health officials say 31 babies in 15 states have been sickened in a growing outbreak of infantile botulism tied to ...

A closer look at the unapproved peptide injections promoted by influencers and celebrities

WASHINGTON (AP) — Unapproved peptide drugs have become a trendy new hack among wellness influencers, fitness coaches and ...

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) ...

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.

FDA names longtime cancer scientist Pazdur to lead drug center

The Food and Drug Administration has named a longtime regulator of cancer medications to lead the agency’s drug center ...

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 ...

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 ...
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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 ...