FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 8, 2024 - 08:58 GMT

FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma

For Immediate Release: August 02, 2024 The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 7, 2024 - 15:39 GMT

FDA Roundup: July 2, 2024

For Immediate Release: July 02, 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 approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 6, 2024 - 21:47 GMT

FDA Roundup: February 6, 2024

For Immediate Release: February 06, 2024 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 issued an outbreak advisory warning consumers not to eat, sell, or serve recalled …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 4, 2024 - 16:37 GMT

FDA Roundup: April 2, 2024

For Immediate Release: April 02, 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 is releasing several scientific review policy memoranda that provide a snapshot of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 2, 2024 - 22:35 GMT

FDA Roundup: February 2, 2024

For Immediate Release: February 02, 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 issued a safety communication to warn consumers, health care providers, and health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 30, 2024 - 22:54 GMT

FDA Roundup: January 30, 2024

For Immediate Release: January 30, 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 published the FDA Voices: “FDA Enhances Global Patient and Regulatory Collaborations in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 26, 2024 - 19:43 GMT

FDA Roundup: January 26, 2024

For Immediate Release: January 26, 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 a new website listing regulations for the Foods Program it plans to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 23, 2024 - 21:26 GMT

FDA Roundup: January 23, 2024

For Immediate Release: January 23, 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 announced the Medical Device Sterilization Town Hall: FDA Activities and Challenges in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 19, 2024 - 21:25 GMT

FDA Roundup: January 19, 2024

For Immediate Release: January 19, 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 issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 16, 2024 - 20:36 GMT

FDA Roundup: January 16, 2024

For Immediate Release: January 16, 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 announced an open period for applications to support the development, implementation, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2024 - 19:56 GMT

FDA Roundup: January 12, 2024

For Immediate Release: January 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA issued a safety alert, advising restaurants and retailers not to serve or sell …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2024 - 15:17 GMT

FDA Roundup: November 1, 2024

For Immediate Release: November 01, 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 published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare …

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Published on January 10, 2024 - 14:41 GMT

FDA Roundup: October 1, 2024

For Immediate Release: October 01, 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 announced seven new clinical trial grants awarded in fiscal year (FY) 2024 under the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2024 - 10:10 GMT

FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect

FDA Statement The following is attributed to Robert M. Califf, M.D., FDA Commissioner, and Jim Jones, Deputy Commissioner for Human Foods and Michael Rogers, Associate Commissioner for Inspections and Investigations For Immediate Release: October 01, 2024 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2024 - 21:55 GMT

FDA Roundup: January 9, 2024

For Immediate Release: January 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 10, please join OCE at 2:00 pm for Conversations on Cancer: Bringing Innovation to People …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2024 - 15:30 GMT

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

FDA News Release Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives For Immediate Release: January 08, 2024 Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 5, 2024 - 19:46 GMT

FDA Roundup: January 5, 2024

For Immediate Release: January 05, 2024 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 …

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Published on January 5, 2024 - 14:44 GMT

FDA Authorizes Florida’s Drug Importation Program

For Immediate Release: January 05, 2024 Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 5, 2024 - 09:20 GMT

FDA Clarifies Approach to Genomic Alterations in Animals

For Immediate Release: May 01, 2024 Today, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s …

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Published on January 3, 2024 - 15:58 GMT

FDA Roundup: March 1, 2024

For Immediate Release: March 01, 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 issued a letter of enforcement discretion for certain qualified health claims regarding …

Distribution channels: Healthcare & Pharmaceuticals Industry