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For Immediate Release: October 04, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders.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