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CDER is closely monitoring the circulating viral variants of SARS-CoV-2 that may impact the use of the monoclonal antibody therapies authorized for emergency use, FDA said about its collaboration with agencies including the Assistant Secretary for Preparedness and Response (ASPR) and CDC

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In addition, the lack of fever and chills helped rule out infections, while the absence of gastrointestinal symptoms, such as rectal bleeding, suggested that an acute gastrointestinal hemorrhage was unlikely