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911 articles found
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FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other DrugsToday, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms)... -
Coronavirus (COVID-19) Update: November 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 Nov. 22, the FDA authorized three over-the-counter (OTC) CO...
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FDA Approves First Drug to Improve Growth in Children with Most Common Form of DwarfismToday, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), m...
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Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine BoostersToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all...
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FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class IIThe following quote is attributed to Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health:...
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Coronavirus (COVID-19) Update: November 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Monday November 15, 2021 the FDA took several important act...
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FDA In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to SpinachThe following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: Español “The FDA, along with the CDC and our state and local partners, is working...
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FDA Authorizes Marketing of Virtual Reality System for Chronic Pain ReductionThe U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral method...
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Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home TestsToday, the U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurat...
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FDA Approves Treatment for Rare Blood DiseaseToday, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blo...