For Immediate Release: March 06, 2026 Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 […]

Docket Number: FDA-2025-D-1504 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine Office of […]

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]

This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st […]

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory […]

Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Premium Health Management Inc. dba Premium Health 1800 E. Garry Ave. Suite 224Santa Ana, CA […]

For Immediate Release: March 05, 2026 The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards […]

Submit Comments by 05/04/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

The U.S. Food and Drug Administration (FDA) has approved Yuviwel (navepegritide) for injection to improve growth in pediatric patients aged two years and older with achondroplasia […]