FDA

FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type…

FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

Today, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with…

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions…

FDA Roundup: August 12, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:   Today, the FDA posted a safety…

FDA Infant Formula Update: August 5, 2022

Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available…

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or…

FDA Roundup: August 5, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:    Today, the FDA cautioned pet owners…

FDA Continues Efforts to Support Innovation in Medical Device Sterilization

The sterilization of medical devices is a vital process for helping to prevent serious infections. The U.S. Food and Drug Administration continually works to oversee…

FDA Roundup: August 2, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA announced the approval…

FDA Roundup: July 29, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Tuesday, the FDA updated the FAQs…