FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

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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 …

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

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 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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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Published on January 3, 2025 - 19:29 GMT

FDA Roundup: January 3, 2025

For Immediate Release: January 03, 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 notice in the Federal Register with its determination that 35 food contact …

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Published on December 27, 2024 - 20:35 GMT

FDA Roundup: December 27, 2024

For Immediate Release: December 27, 2024 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 announced recommended changes to labeling for transmucosal buprenorphine products …

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Published on December 26, 2024 - 17:23 GMT

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic ...

For Immediate Release: December 26, 2024 Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2024 - 16:38 GMT

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

For Immediate Release: December 23, 2024 Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 20, 2024 - 22:32 GMT

FDA Approves First Medication for Obstructive Sleep Apnea

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced- …

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Published on December 20, 2024 - 20:27 GMT

FDA Roundup: December 20, 2024

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided answers to a set of FAQs about software functions that may be described as …

Distribution channels: Healthcare & Pharmaceuticals Industry