FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 9, 2024 - 14:25 GMT

La FDA autoriza la vacuna contra el COVID-19 de Novavax actualizada para brindar una mejor protección contra las variantes que ...

For Immediate Release: August 30, 2024 English Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) otorgó una autorización de uso de emergencia (EUA, por sus siglas en inglés) para una versión …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 8, 2024 - 20:49 GMT

FDA Roundup: March 8, 2024

For Immediate Release: March 08, 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 proposed new regulations to provide animal drug sponsors with predictable …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 8, 2024 - 20:06 GMT

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

For Immediate Release: March 08, 2024 Today, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 6, 2024 - 20:36 GMT

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

For Immediate Release: March 06, 2024 The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2024 - 22:52 GMT

FDA Roundup: March 5, 2024

For Immediate Release: March 05, 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 availability of a final guidance for industry titled “Dietary Supplements: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2024 - 21:43 GMT

FDA Clears First Over-the-Counter Continuous Glucose Monitor

For Immediate Release: March 05, 2024 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2024 - 15:28 GMT

FDA Roundup: May 3, 2024

For Immediate Release: May 03, 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 availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 4, 2024 - 15:27 GMT

FDA Approves New Antibiotic for Three Different Uses

For Immediate Release: April 03, 2024 Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2024 - 19:34 GMT

FDA, Industry Actions End Sales of PFAS Used in US Food Packaging

FDA News Release The following is attributed to Jim Jones, Deputy Commissioner for Human Foods For Immediate Release: February 28, 2024 Today, the U.S. Food and Drug Administration is announcing that grease-proofing materials containing per- and …

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Published on February 27, 2024 - 21:16 GMT

FDA Roundup: February 27, 2024

For Immediate Release: February 27, 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 announced that on May 16, 2024, the FDA’s Vaccines and Related Biological Products …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 23, 2024 - 22:26 GMT

FDA Roundup: February 23, 2024

For Immediate Release: February 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 its final decision to withdraw approval of Pepaxto (melphalan flufenamide), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 20, 2024 - 23:14 GMT

FDA Roundup: February 20, 2024

For Immediate Release: February 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 published an interview with Dr. June Raine, CEO of the Medicines and Healthcare …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 ( …

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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 …

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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 …

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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 …

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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 …

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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