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256 articles found
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FDA Approves Two Oral Therapies to Treat GonorrheaThe U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.The FDA today approved Nuzolvence (zoliflodacin) granul... -
FDA Proposes Expanding Sunscreen Active Ingredient ListToday, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is prop...
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FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic AnemiaThe U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic ane...
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FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever TickToday, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, a...
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FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal AntibodiesToday, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or r...
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FDA Expands Artificial Intelligence Capabilities with Agentic AI DeploymentThe U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows...
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FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver InjuryThe U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent sa...
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HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement TherapyThe U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After more than two decades of fear and misinformation surrou...
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HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement TherapyThe U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After more than two decades of fear and misinformation surrou...
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FDA Awards Second Batch of National Priority VouchersThe U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of vou...