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911 articles found
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Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses AvailableToday, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses... -
FDA is Investigating Reports of Infections Associated with Reprocessed Urological EndoscopesToday, the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with...
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Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test DevelopmentFollowing recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Toda...
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Coronavirus (COVID-19) Update: March 30, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The agency has updated its FDA COVID-19 Response At-A-Glance S...
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FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care SettingsToday, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent...
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FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple MyelomaThe U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has...
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Coronavirus (COVID-19) Update: March 26, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 23, 2021, the FDA issued an emergency use authorizati...
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FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis PatientsToday, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (...
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FDA Approves First in the World Device to Treat Patients with Congenital Heart DiseaseToday, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outfl...
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FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric PatientsToday, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to t...