FDA News Update: FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

by David Randall | Apr 14, 2025 | FDA, Trending News

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A...

FDA News Update: Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

by David Randall | Apr 10, 2025 | FDA, Trending News

For Immediate Release: April 01, 2025 Renowned surgeon-scientist and health policy expert, Martin A. Makary, M.D., M.P.H., took the oath of office to become the 27th Commissioner of Food and Drugs. Dr. Makary was confirmed by a bipartisan vote of the U.S. Senate.“I am...

FDA Update: New Tool Shows Chemical Contaminant Levels in Food for Greater Transparency

by David Randall | Mar 27, 2025 | FDA, Trending News

For Immediate Release: March 20, 2025 Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online...

FDA Update: New Kidney Drug Approved, Medical Device Alert Issued, and Colonoscopy Cleaner AuthorizedFDA Roundup: March 21, 2025

by David Randall | Mar 27, 2025 | FDA, Trending News

For Immediate Release: March 21, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G)...

FDA News Update: First Nicotine Pouches Receive Marketing Authorization Under Premarket Review

by David Randall | Feb 12, 2025 | FDA, Trending News

For Immediate Release: January 16, 2025 Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first...