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117 articles found
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Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain LimitationsToday, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to e... -
FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused MedicationToday, the U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid...
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FDA Roundup: February 18, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA is announcing that it has found an additional four lots of AstraZeneca CO...
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FDA Roundup: January 14, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the Interagency Food Safety Analytics Collaboration — a collaboration between the...
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Coronavirus (COVID-19) Update: December 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Wednesday, the FDA updated the SARS-CoV-2 Viral Mutatio...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain AdultsToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with po...
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Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
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FDA Approves First Injectable Treatment for HIV Pre-Exposure PreventionToday, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds...
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Coronavirus (COVID-19) Update: December 17, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 15, 2021, the FDA approved an abbreviated new...
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Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain IndividualsToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-expo...