The Latest Breaking News from FDA

Praxis shares soar as the biotech firm reports promising late-stage results for ulixacaltamide. Here’s why it may not be too late to invest in PRAX shares.

Novartis A/S (NYSE:NVS) on Thursday shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).

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