FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 11, 2025 - 21:10 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2025 - 19:46 GMT

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

For Immediate Release: April 10, 2025 Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 18:34 GMT

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

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 17:57 GMT

FDA Roundup: March 28, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 14:04 GMT

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 21, 2025 - 20:55 GMT

FDA Roundup: March 21, 2025

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 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 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 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:

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

Published on January 17, 2025 - 21:19 GMT

FDA Roundup: January 17, 2025

For Immediate Release: January 17, 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 announced the release of a new prevention strategy aimed at combating the contamination …

Distribution channels: Healthcare & Pharmaceuticals Industry