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105 articles found
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FDA Roundup: June 2, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided an update on medical device reports it received that are report... -
FDA Roundup: May 30, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA issued the Adjusting for Covariates in Randomized Clinical Trials fo...
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FDA Roundup: May 26, 2023Today, 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 flavor...
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FDA Roundup: May 23, 2023Today, 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...
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FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis BullosaToday, 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 d...
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FDA Roundup: May 19, 2023Today, 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 Medi...
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FDA Roundup: May 16, 2023Today, 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 p...
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FDA Roundup: May 12, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated information on medical device shortages on the FDA.gov website t...
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FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood DonationsToday, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitte...
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FDA Approves First Respiratory Syncytial Virus (RSV) VaccineToday, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower...