For Immediate Release: August 04, 2025 WASHINGTON — The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently …
FDA News Release Medication Can be Given Up to Once Every 2 Months 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 …
For Immediate Release: March 28, 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’s Learning and Education to ADvance and Empower Rare Disease Drug Developers …
FDA News Release Today’s Action also Opens the 510(k) Pathway for Other Home Tests for Sexually Transmitted Infections For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for …
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 …
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 …
For Immediate Release: March 18, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Tuesday, March 18, the United States District Court for the District of Maryland entered a consent …
For Immediate Release: March 18, 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 is taking steps to enhance its efforts to ensure the ongoing quality, …
For Immediate Release: March 14, 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 posted information on the flu vaccine composition for the 2025-2026 U.S. flu season. …
FDA News Release Ads Helped Reduce Youth E-Cigarette Use to Lowest Level in a Decade For Immediate Release: March 14, 2025 Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette …
For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. …
For Immediate Release: September 03, 2025 The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very …
For Immediate Release: March 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …
For Immediate Release: March 04, 2025 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 approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the …
For Immediate Release: February 28, 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 Odactra to include use in individuals 5 through 11 years of age to treat …
For Immediate Release: February 21, 2025 Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid …
FDA News Release Agency Continues Efforts to Increase Access to Insulin Treatment Options For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) …
For Immediate Release: December 02, 2025 The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products— …
For Immediate Release: December 02, 2025 Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced. The …
For Immediate Release: September 02, 2025 The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, …
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