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 […]

Podcast Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from […]

Summary Company Announcement Date: March 24, 2026 FDA Publish Date: March 24, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description A Magnesium Sulfate in […]

Save the Date Agenda Coming Soon Register Here Visit CDER Small Business and Industry Assistance (SBIA) Homepage Drugs, Devices, and Biologics Tracks will Offer an Opportunity […]

Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and Type 2 diabetes. To […]

La Administración de Alimentos y Medicamentos (Food and Drug Administration, FDA) está reforzando una advertencia existente de que el estreñimiento causado por el medicamento para tratar […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: 320-26-54 Product: Drugs Recipient: Recipient Name Mr. Jingcheng Gao Recipient Title General Manager Yangzhou H&R […]