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911 articles found
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FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety ReviewFollowing a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and... -
Coronavirus (COVID-19) Update: April 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the agency’s regulatory processes for reviewing all...
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FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke PatientsToday, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for...
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FDA Approves Immunotherapy for Endometrial Cancer with Specific BiomarkerToday, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or follow...
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FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 VaccinesThe U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure th...
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Coronavirus (COVID-19) Update: April 20, 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 took steps to further facilitate the authorizat...
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FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing ProgramsThe following quote is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health Español Today, the U.S. Food and Drug Administration took...
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Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody BamlanivimabToday, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be...
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Coronavirus (COVID-19) Update: April 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...
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FDA Approves First Immunotherapy for Initial Treatment of Gastric CancerToday, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric c...