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911 articles found
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FDA Approves Prescription Nasal Spray to Reverse Opioid OverdoseToday, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric pat... -
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 Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin DeliveryToday, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices,...
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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 Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by MenopauseToday, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah...
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FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s DiseaseToday, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s...
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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 Roundup: May 09, 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 granted marketing authorization of the VITROS Immunodiagnostic Produ...