FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 10, 2024 - 17:52 GMT

FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities

For Immediate Release: October 07, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2024 - 20:29 GMT

FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose

FDA News Release Agency Continues to Support Development of Overdose Reversal Drugs including Naloxone and Nalmefene For Immediate Release: August 07, 2024 Today, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2024 - 15:20 GMT

FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation

For Immediate Release: July 08, 2024 Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 19:02 GMT

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

For Immediate Release: June 27, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 26, 2024 - 15:15 GMT

FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies

For Immediate Release: June 26, 2024 Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2024 - 20:10 GMT

FDA Roundup: June 25, 2024

For Immediate Release: June 25, 2024 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 Small Entity Compliance Guide to assist small entities in complying with the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 21, 2024 - 19:15 GMT

FDA Roundup: June 21, 2024

For Immediate Release: June 21, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published final guidance titled Circumstances that Constitute Delaying, Denying, Limiting, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 21, 2024 - 14:52 GMT

FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review

FDA News Release Authorization Includes Restrictions to Mitigate Youth Risk For Immediate Release: June 21, 2024 Following an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 20, 2024 - 21:37 GMT

FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy

For Immediate Release: June 20, 2024 Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 18, 2024 - 19:29 GMT

FDA Roundup: June 18, 2024

For Immediate Release: June 18, 2024 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 input about patient safety associated with certain medical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 14, 2024 - 20:23 GMT

FDA Roundup: June 14, 2024

For Immediate Release: June 14, 2024 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 proposed exemption for certain cottage cheese products from the requirements of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 12, 2024 - 15:43 GMT

Biden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle Organics

FDA News Release Biden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle Organics For Immediate Release: June 12, 2024 Today, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), …

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Published on June 12, 2024 - 15:08 GMT

FDA Roundup: December 6, 2024

For Immediate Release: December 06, 2024 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 published the draft guidance, “Expedited Program for Serious Conditions — …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 11, 2024 - 19:56 GMT

FDA Roundup: June 11, 2024

For Immediate Release: June 11, 2024 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 advisory warning consumers and retailers to not eat, sell, or serve any flavor …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2024 - 16:33 GMT

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes

For Immediate Release: June 10, 2024 The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Along …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 9, 2024 - 15:43 GMT

FDA Roundup: September 6, 2024

For Immediate Release: September 03, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Sept. 11 from 1-2 p.m. ET, the FDA will host a virtual Medical Device Sterilization Town Hall: …

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Published on June 8, 2024 - 13:49 GMT

FDA Roundup: August 6, 2024

For Immediate Release: August 06, 2024 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 Alert advising restaurants and retailers not to serve or sell, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2024 - 20:12 GMT

FDA Roundup: June 7, 2024

For Immediate Release: June 07, 2024 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 that it has advised the manufacturers of the licensed and authorized COVID-19 …

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Published on May 31, 2024 - 20:54 GMT

FDA Roundup: May 31, 2024

For Immediate Release: May 31, 2024 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 mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 30, 2024 - 21:30 GMT

FDA, USDA, EPA enhance efforts to reduce food loss and waste, welcome USAID to interagency collaborative

For Immediate Release: May 30, 2024 The U.S. Food and Drug Administration announced today the signing of a formal agreement with the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) to renew their Federal Interagency …

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