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117 articles found
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FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including NewbornsToday, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighi... -
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)...
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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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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...
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Coronavirus (COVID-19) Update: October 22, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA began posting materials for the next Vaccine an...
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Coronavirus (COVID-19) Update: October 19, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Oct. 12, the FDA approved an abbreviated new drug applicati...
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FDA Approves Cyltezo, the First Interchangeable Biosimilar to HumiraThe U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is bo...
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Coronavirus (COVID-19) Update: October 12, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today the FDA announced that it intends to withdraw, effective...
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FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of SunscreensThe U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter...