FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 12, 2023 - 14:58 GMT

FDA Provides Draft Recommendations to Help Reduce Microbial Contamination in Tattoo Inks

For Immediate Release: June 12, 2023 Today, the U.S. Food and Drug Administration issued a draft guidance to help manufacturers and distributors recognize situations that will prevent microbial contamination in tattoo inks. “With about 30 percent of people …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2023 - 15:53 GMT

FDA Roundup: October 6, 2023

For Immediate Release: October 06, 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 updated its infant formula compliance program for FDA investigators, laboratory …

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Published on June 9, 2023 - 19:38 GMT

FDA Roundup: June 9, 2023

For Immediate Release: June 09, 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 provided information to health care providers and facilities on oxygenator devices used in …

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Published on June 7, 2023 - 16:57 GMT

FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval

For Immediate Release: July 06, 2023 Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial …

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Published on June 6, 2023 - 19:58 GMT

FDA Roundup: June 6, 2023

For Immediate Release: June 06, 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 Letter to Health Care Providers recommending health care facilities and …

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Published on June 6, 2023 - 19:24 GMT

FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

For Immediate Release: June 06, 2023 Español Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect …

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Published on June 6, 2023 - 14:25 GMT

FDA Announces Additional Steps to Modernize Clinical Trials

FDA News Release Agency Requesting Feedback on the Draft Recommendations and How They Should Be Applied to Increasingly Diverse Trial Types and Data Sources For Immediate Release: June 06, 2023 Today, the U.S. Food and Drug Administration is announcing the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 31, 2023 - 14:48 GMT

FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes

For Immediate Release: May 31, 2023 Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff …

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Published on May 30, 2023 - 20:14 GMT

FDA Roundup: May 30, 2023

For Immediate Release: May 30, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …

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Published on May 30, 2023 - 15:48 GMT

FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information

For Immediate Release: May 30, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Providing people with accurate and timely information to help them take their prescription medications safely and …

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Published on May 26, 2023 - 19:22 GMT

FDA Roundup: May 26, 2023

For Immediate Release: May 26, 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 warning letters to firms responsible for two popular flavored, disposable e- …

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Published on May 25, 2023 - 14:08 GMT

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at …

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Published on May 23, 2023 - 21:35 GMT

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

For Immediate Release: May 23, 2023 FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment …

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Published on May 23, 2023 - 20:25 GMT

FDA Roundup: May 23, 2023

For Immediate Release: May 23, 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 and the Veterans Health Administration announced a new collaboration to jointly develop …

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Published on May 23, 2023 - 19:48 GMT

FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder

For Immediate Release: May 23, 2023 Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available …

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Published on May 22, 2023 - 23:15 GMT

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

FDA News Release Nalmefene Hydrochloride Product in Nasal Spray Form Provides Additional Tool for Harm Reduction Groups and First Responders For Immediate Release: May 22, 2023 Today, the U.S. Food and Drug Administration approved Opvee, the first …

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Published on May 19, 2023 - 19:36 GMT

FDA Roundup: May 19, 2023

For Immediate Release: May 19, 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 that the National Academies of Sciences, Engineering, and Medicine (NASEM) will …

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Published on May 19, 2023 - 17:58 GMT

FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic …

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Published on May 19, 2023 - 15:39 GMT

FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

FDA News Release Agency Continues to Support Innovation of Next-Generation Technology in Diabetes Management For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing …

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Published on May 16, 2023 - 18:09 GMT

FDA Roundup: May 16, 2023

For Immediate Release: May 16, 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 updated its new Rumor Control page to provide the facts and inform the public on how the …

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