FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

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For Immediate Release: October 04, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders.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

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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 …

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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 …

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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 …

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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 …

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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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Published on March 30, 2023 - 09:52 GMT

FDA Roundup: March 28, 2023

For Immediate Release: March 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 released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant …

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Published on March 30, 2023 - 09:52 GMT

FDA Approves First Over-the-Counter Naloxone Nasal Spray

For Immediate Release: March 29, 2023 Español Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use …

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Published on March 24, 2023 - 19:39 GMT

FDA Roundup: March 24, 2023

For Immediate Release: March 24, 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 finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement …

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Published on March 24, 2023 - 14:44 GMT

FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels

For Immediate Release: March 24, 2023 The U.S. Food and Drug Administration today issued draft guidance that provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products to ensure the …

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Published on March 24, 2023 - 13:50 GMT

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support …

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Published on March 24, 2023 - 12:32 GMT

FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake

For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes. The proposed rule would help …

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Published on March 21, 2023 - 19:43 GMT

FDA Roundup: March 21, 2023

For Immediate Release: March 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 completed its second pre-market consultation for a human food made from cultured animal …

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