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Published on February 16, 2024 - 22:43 GMT

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

For Immediate Release: February 16, 2024 Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 16, 2024 - 20:43 GMT

FDA Roundup: February 16, 2024

For Immediate Release: February 16, 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 reminded consumers in 5 Medication Safety Tips for Older Adults that even if …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 16, 2024 - 17:50 GMT

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

For Immediate Release: February 16, 2024 Today, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 14, 2024 - 14:59 GMT

FDA Approves First Medication to Treat Severe Frostbite

For Immediate Release: February 14, 2024 Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. “This approval provides patients with the first …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 13, 2024 - 17:47 GMT

FDA Roundup: February 13, 2024

For Immediate Release: February 13, 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 posted warning letters to US Chem Labs and Synthetix Inc. doing business as Helix …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 9, 2024 - 20:55 GMT

FDA Roundup: February 9, 2024

For Immediate Release: February 09, 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Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued draft guidance for industry to provide recommendations for collecting …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 8, 2024 - 15:10 GMT

FDA Roundup: August 2, 2024

For Immediate Release: August 02, 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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. …

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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