Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-2003-D-0431 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Veterinary Medicine Office of Inspections and Investigations Office of the […]

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection to reduce proteinuria (protein in the urine) in adults with primary immunoglobulin […]

On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, […]

Cosmetics Drugs Medical Devices Radiation-Emitting Products Tobacco Vaccines, Blood, Biologics The Center for Biologics, Evaluation and Research’s (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Product: Drugs Recipient: Recipient Name Andrew C. Corbin Recipient Title CEO/CFO Wells Pharma of Houston, LLC 9265 […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 17, 2025 RE: 716286 Mahesh Chada: […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Hiren Gaglani Recipient Title Director Handelnine Global, LLC dba Navafresh 4300 S. Clinton Ave.South Plainfield, NJ 07080United […]