FDA Press Releases - EIN Presswire - Press Release Distribution Service

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— …

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FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies

For Immediate Release: December 02, 2025 Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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, …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

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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 …

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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

Published on January 16, 2025 - 16:08 GMT

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 15, 2025 - 14:38 GMT

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other ...

For Immediate Release: January 15, 2025 Today, the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine …

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Published on January 14, 2025 - 20:59 GMT

FDA Roundup: January 14, 2025

For Immediate Release: January 14, 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 issued a Request for Information (RFI) on industry practices related to poppy seeds. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 14, 2025 - 14:38 GMT

FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods

For Immediate Release: January 14, 2025 Image Today, the U.S. Food and Drug Administration is announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package (FOP) nutrition label for most packaged …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2025 - 15:04 GMT

FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

For Immediate Release: December 01, 2025 The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows — harnessing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2025 - 20:09 GMT

FDA Roundup: January 10, 2025

For Immediate Release: January 10, 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 released a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant …

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Published on January 7, 2025 - 21:47 GMT

FDA Roundup: January 7, 2025

For Immediate Release: January 07, 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 posted warning letters sent to six firms selling unapproved drugs that claim to treat …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 17:04 GMT

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 15:54 GMT

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 15:27 GMT

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

FDA News Release Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 14:17 GMT

FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to estimate the …

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