Registrants, including repackers and relabelers, are required under federal law to report annually to the agency the amount of each listed drug that was manufactured, prepared, […]

Alyglo (immune globulin intravenous, human-stwk) Increased hypersensitivity reactions in patients receiving certain product lots FDA is evaluating the need for regulatory action. Bispecific T-cell engager therapies […]

[3-30-2026] The Food and Drug Administration is advising consumers not to purchase or use Red Bull Extreme or Blue Bull Extreme, products promoted and sold for […]

[3-30-2026] The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Honey, a product promoted and sold for sexual enhancement on […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

What is the GDUFA Science & Research Program? The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) continually advances scientific understanding […]

For Immediate Release: March 25, 2026 The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II […]

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment […]