FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 11, 2023 - 16:59 GMT

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. …

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Published on September 11, 2023 - 14:28 GMT

FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in …

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Published on September 11, 2023 - 14:06 GMT

FDA Clears First COVID-19 Home Antigen Test

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for …

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Published on August 30, 2023 - 20:24 GMT

FDA Issues Warning Letters to Three Infant Formula Manufacturers

For Immediate Release: August 30, 2023 Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is …

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Published on August 29, 2023 - 19:15 GMT

FDA Roundup: August 29, 2023

For Immediate Release: August 29, 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 informed consumers in Treating and Dealing with ADHD about FDA-approved treatments …

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Published on August 25, 2023 - 20:03 GMT

FDA Roundup: August 25, 2023

For Immediate Release: August 25, 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 the signing of a first-of-its kind Regulatory Partnership Arrangement with …

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Published on August 24, 2023 - 21:21 GMT

FDA Approves First Biosimilar to Treat Multiple Sclerosis

For Immediate Release: August 24, 2023 The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 23, 2023 - 16:23 GMT

FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program

For Immediate Release: August 23, 2023 Today, the U.S. Food and Drug Administration is announcing the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. The new executive position will lead the charge in setting and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 21, 2023 - 21:46 GMT

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

For Immediate Release: August 21, 2023 Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and …

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Published on August 18, 2023 - 20:26 GMT

FDA Roundup: August 18, 2023

For Immediate Release: August 18, 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 provided an update to the list of ultraviolet (UV) wand products that may present …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 15, 2023 - 20:00 GMT

FDA Roundup: August 15, 2023

For Immediate Release: August 15, 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 a request for information on a citizen petition asking the FDA to amend the …

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Published on August 13, 2023 - 23:59 GMT

FDA Roundup: August 11, 2023

For Immediate Release: August 11, 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 an Outbreak Advisory for an investigation of Listeria monocytogenes …

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Published on August 12, 2023 - 14:10 GMT

FDA Roundup: December 8, 2023

For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certain PMA …

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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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