FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 20, 2025 - 18:39 GMT

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 18, 2025 - 19:16 GMT

FDA Roundup: March 18, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 18, 2025 - 18:36 GMT

HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families

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, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 14, 2025 - 19:41 GMT

FDA Roundup: March 14, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 14, 2025 - 14:24 GMT

FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2025 - 18:44 GMT

FDA Announces Leadership Appointments at Center for Drug Evaluation and Research

For Immediate Release: December 03, 2025 The U.S. Food and Drug Administration (FDA) today announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER). A physician and epidemiologist …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2025 - 18:22 GMT

FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity

For Immediate Release: December 03, 2025 The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation. Avance is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2025 - 19:40 GMT

FDA Roundup: March 11, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 9, 2025 - 13:59 GMT

FDA Advances Rare Disease Drug Development with New Evidence Principles

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 7, 2025 - 20:59 GMT

FDA Roundup: March 7, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 4, 2025 - 21:43 GMT

FDA Roundup: March 4, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2025 - 21:18 GMT

FDA Roundup: February 28, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 21, 2025 - 17:01 GMT

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

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 …

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Published on February 14, 2025 - 20:48 GMT

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 12, 2025 - 16:41 GMT

FDA Seizes 7-OH Opioids to Protect American Consumers

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— …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 12, 2025 - 09:58 GMT

FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies

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 …

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Published on February 9, 2025 - 10:59 GMT

FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure

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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Published on February 6, 2025 - 15:15 GMT

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

For Immediate Release: June 02, 2025 The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2025 - 17:10 GMT

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes ...

FDA News Release Missed Alerts Can Be Caused by Hardware and Software Changes, Updates and Configurations For Immediate Release: February 05, 2025 Today, the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 30, 2025 - 23:16 GMT

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

FDA News Release First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved …

Distribution channels: Healthcare & Pharmaceuticals Industry