The Office of Biostatistics (OB) conducts independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process for publication. OB research spans such […]

For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth […]

FDA researchers are investigating the utility of pharmacodynamic, or PD, biomarkers to demonstrate biosimilarity. This research can potentially help developers demonstrate that their proposed product is […]

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Michael Strobel Recipient Title CEO Aurora Pharmaceutical 1196 Highway 3 SouthNorthfield, MN 55057United States Issuing Office: Center for Veterinary […]

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Jeffrey Simmons Recipient Title President and CEO Elanco Animal Health 2500 Innovation WayGreenfield, IN 46140United States Issuing Office: Center […]

On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years […]

[9-18-2025] The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on […]

Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

On This Page Date: October 15 – 16, 2025 Day1: Wed, Oct 15 8:30 a.m. – 05:00 p.m. ET Day2: Thu, Oct 16 8:30 a.m. – […]