FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 12, 2023 - 11:10 GMT

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 …

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Published on August 11, 2023 - 12:11 GMT

FDA Approves New Medication for Chronic Weight Management

For Immediate Release: November 08, 2023 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or …

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Published on August 9, 2023 - 17:47 GMT

FDA Roundup: September 8 2023

For Immediate Release: September 08, 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’s Center for Devices and Radiological Health (CDRH) published a Postmarket …

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Published on August 8, 2023 - 20:31 GMT

FDA Roundup: August 8, 2023

For Immediate Release: August 08, 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 announced it is issuing a direct final rule to complete administrative actions that …

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Published on August 8, 2023 - 13:46 GMT

La FDA aprueba el primer tratamiento oral para la depresión posparto

For Immediate Release: August 04, 2023 El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Zurzuvae (zuranolona), el primer medicamento oral indicado para tratar la depresión posparto ( …

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Published on July 28, 2023 - 20:37 GMT

FDA Roundup: July 28, 2023

For Immediate Release: July 28, 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 approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire …

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Published on July 28, 2023 - 17:11 GMT

FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product

For Immediate Release: July 28, 2023 Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid …

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Published on July 27, 2023 - 14:22 GMT

FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder

For Immediate Release: July 27, 2023 Today, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to …

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Published on July 25, 2023 - 19:23 GMT

FDA Roundup: July 25, 2023

For Immediate Release: July 25, 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 reopened the comment period for the 30-day procedural notice to conduct a study …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 21, 2023 - 22:46 GMT

FDA Provides Update Regarding Storm Damage at Pfizer Facility in North Carolina

For Immediate Release: July 21, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at …

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Published on July 21, 2023 - 20:09 GMT

FDA Roundup: July 21, 2023

For Immediate Release: July 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 Center for Tobacco Products (CTP) announced that the center will host a virtual listening …

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Published on July 18, 2023 - 20:17 GMT

FDA Roundup: July 18, 2023

For Immediate Release: July 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 announced the findings from the voluntary pilot program to evaluate alignment of …

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Published on July 17, 2023 - 17:30 GMT

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

For Immediate Release: July 17, 2023 Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 14, 2023 - 19:56 GMT

FDA Roundup: July 14, 2023

For Immediate Release: July 14, 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 re-issued two temporary guidances originally published during the COVID-19 public …

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Published on July 13, 2023 - 13:32 GMT

FDA Approves First Nonprescription Daily Oral Contraceptive

For Immediate Release: July 13, 2023 Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. …

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Published on July 11, 2023 - 20:20 GMT

FDA Roundup: July 11, 2023

For Immediate Release: July 11, 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’s Center for Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine …

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Published on July 11, 2023 - 15:38 GMT

FDA Roundup: November 7, 2023

For Immediate Release: November 07, 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 issued a Safety Communication warning consumers, health care providers, and health …

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Published on July 8, 2023 - 10:07 GMT

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

For Immediate Release: August 07, 2023 Today, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including …

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Published on July 7, 2023 - 20:43 GMT

FDA Roundup: July 7, 2023

For Immediate Release: July 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 U.S. Embassy & Consulates in India published a news release highlighting "Operation …

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Published on June 30, 2023 - 18:45 GMT

FDA Roundup: June 30, 2023

For Immediate Release: June 30, 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’s Center for Tobacco Products (CTP) Director Brian King published a statement …

Distribution channels: Healthcare & Pharmaceuticals Industry