FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 22, 2023 - 18:19 GMT

FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in …

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Published on June 22, 2023 - 17:22 GMT

FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco ...

For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 20, 2023 - 21:15 GMT

FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes

For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 …

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Published on June 20, 2023 - 19:36 GMT

FDA Roundup: June 20, 2023

For Immediate Release: June 20, 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 its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and …

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Published on June 20, 2023 - 13:50 GMT

FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers

FDA News Release Pilot Geared Toward Sponsors of Certain Oncology Drug Products Used with Certain In Vitro Diagnostic Tests to Identify Patients for Certain Cancer Treatments For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration …

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Published on June 16, 2023 - 20:01 GMT

FDA Roundup: June 16, 2023

For Immediate Release: June 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 posted information on its website regarding the formula for COVID-19 vaccines for the 2023 …

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Published on June 14, 2023 - 04:56 GMT

FDA Roundup: June 13, 2023

For Immediate Release: June 13, 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 published the FDA Voices: “Accelerating Rare disease Cures (ARC) Program Emerges as a …

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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 …

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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 …

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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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