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Office of the Commissioner

Articles by Office of the Commissioner

FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s - fda.gov

BusinessMarch 5, 2026

For Immediate Release: March 03, 2026 The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regardinâ...

FDA Takes New Approach to "No Artificial Colors" Claims - fda.gov

BusinessFebruary 7, 2026

For Immediate Release: February 05, 2026 Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nations food supply from the use of artificial petroleum…...

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation - fda.gov

BusinessJanuary 13, 2026

For Immediate Release: January 11, 2026 The U.S. Food and Drug Administration today announced it is sharing information about the agencys flexible approach to overseeing chemistry, manufacturing an…...

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews - fda.gov

BusinessDecember 16, 2025

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications revi…...

FDA Approves Two Oral Therapies to Treat Gonorrhea - fda.gov

BusinessDecember 13, 2025

For Immediate Release: December 12, 2025 The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea. The FDA t…...

FDA Proposes Expanding Sunscreen Active Ingredient List - fda.gov

BusinessDecember 12, 2025

For Immediate Release: December 11, 2025 Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office …...

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity - fda.gov

BusinessDecember 11, 2025

For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CN…...

FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US - fda.gov

BusinessDecember 6, 2025

For Immediate Release: December 04, 2025 The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T…...