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911 articles found
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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... -
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... -
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... -
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... -
FDA Warns Companies Over Illegal Marketing of Botox and Related ProductsThe U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware... -
FDA Acts to Protect Children from Unapproved Fluoride Drug ProductsThe U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies out... -
FDA Moves to Accelerate Biosimilar Development and Lower Drug CostsThe U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologi... -
FDA Issues Emergency Use Authorization for New World Screwworm Drug for DogsThe U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Credelio (lotilaner) chewable tablets, concluding that, based on the scientific evidence available, it is re... -
FDA Publishes Filing Checklists to Prevent Submission DelaysThe U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete an... -
FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in CattleToday, the U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations,...