The Latest Breaking News from FDA

Four brands have been added to the FDA’s ongoing health alert within the last week

There have currently been no reported illnesses as a result of the contamination, the FDA reports

Supplements like protein powders are not regulated by the U.S. Food and Drug Administration

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The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.’s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

On Tuesday, the U.S. Food and Drug Administration (FDA) accepted Rocket Pharmaceuticals, Inc.’s (NASDAQ:RCKT) resubmission of the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; marne-cel), a lentiviral vector (LV)-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I).

Telix Pharmaceuticals (NASDAQ:TLX) updated on Tuesday its commercial and operational performance for the third quarter of fiscal 2025.

Millions of Americans are living with Alzheimer’s and hundreds of thousands are diagnosed each year

FDA has added to list of brands and products that may have been contaminated with cesium-137, a human-made radioactive substance that can cause cancer

Intuitive Surgical has attracted recent congressional buying ahead of its next quarterly earnings results, implying a new potential bull run

In addition to new recipes, PepsiCo hopes to introduce fresh packaging for its beloved snacks