FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 7, 2023 - 10:38 GMT

FDA, FTC Warn Six Companies for Illegally Selling Copycat Food Products Containing Delta-8 THC

For Immediate Release: July 05, 2023 Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to six companies for illegally selling copycat food products containing Delta-8 tetrahydrocannabinol, also known as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 5, 2023 - 17:50 GMT

FDA Roundup: May 05, 2023

For Immediate Release: May 05, 2023 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 issued a safety communication to warn consumers and health care providers to stop …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2023 - 19:53 GMT

FDA Roundup: April 28, 2023

For Immediate Release: April 28, 2023 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 final guidance for industry titled Smoking Cessation and Related Indications: …

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Published on April 26, 2023 - 22:04 GMT

FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile ...

For Immediate Release: April 26, 2023 Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) …

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Published on April 21, 2023 - 19:43 GMT

FDA Roundup: April 21, 2023

For Immediate Release: April 21, 2023 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 the MiniMed 780G System for modifications to the SmartGuard (SG) Technology and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 18, 2023 - 19:57 GMT

FDA Roundup: April 18, 2023

For Immediate Release: April 18, 2023 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 granted marketing authorization to the NTX100 Tonic Motor Activation (NTX100 ToMAc) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 18, 2023 - 13:30 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

For Immediate Release: April 18, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 17, 2023 - 17:19 GMT

FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

For Immediate Release: April 17, 2023 Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white …

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Published on April 14, 2023 - 21:17 GMT

FDA Roundup: April 14, 2023

For Immediate Release: April 14, 2023 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 an emergency use authorization (EUA) for the Azure Fastep COVID-19 Antigen Pen …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2023 - 09:04 GMT

FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste

FDA News Release Public Comment Sought on Draft National Strategy That Aims to Reduce Food Loss and Waste in the U.S. For Immediate Release: December 04, 2023 The U.S. Food and Drug Administration, the U.S. Department of Agriculture (USDA) and the U.S. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 11, 2023 - 18:40 GMT

FDA Roundup: April 11, 2023

For Immediate Release: April 11, 2023 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 authorized for marketing the MISHA Knee System, an implant placed alongside the knee …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2023 - 09:20 GMT

FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders

For Immediate Release: October 04, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2023 - 18:49 GMT

FDA Approves First Oral Treatment for Postpartum Depression

For Immediate Release: August 04, 2023 Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2023 - 17:11 GMT

FDA Roundup: August 4, 2023

For Immediate Release: August 04, 2023 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 new guidance for immediate implementation, “Recommended Acceptable Intake …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 7, 2023 - 20:42 GMT

FDA Roundup: April 7, 2023

For Immediate Release: April 07, 2023 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 recall notice about Philips Respironics Recall Certain Reworked DreamStations …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2023 - 14:15 GMT

FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena

For Immediate Release: April 06, 2023 Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk …

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Published on April 5, 2023 - 14:19 GMT

La FDA aprueba la primera vacuna contra el virus sincitial respiratorio (VRS)

For Immediate Release: May 04, 2023 Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Arexvy, la primera vacuna contra el virus sincitial respiratorio (VRS, por sus siglas en inglés) aprobada …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 4, 2023 - 19:01 GMT

FDA Roundup: April 4, 2023

For Immediate Release: April 04, 2023 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 #278, Human User Safety in New and Abbreviated New …

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Published on March 31, 2023 - 21:05 GMT

FDA Roundup: March 31, 2023

For Immediate Release: March 31, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: This week, the FDA approved three first-time generic animal drugs, bringing additional options to the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 30, 2023 - 09:52 GMT

FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula Market

For Immediate Release: March 28, 2023 Español Today, the U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continue to have …

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