Culture Wars Reach Labeling For COVID-19 Treatments
Senators ask US FDA to change statements in COVID-19 monoclonal antibody fact sheets that factors like race or ethnicity may place a patient high-risk of serious illness, saying they promote racist decisions.
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US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.
Republicans Ratchet Up Attacks On US FDA’s COVID Response
Pair of letters that target research focus and therapeutic review speed is a potential preview of the kind of oversight that the agency may be subject to if the GOP retakes control of the House this fall.
Califf Confident Public Trust In US FDA Will Be Rebuilt
Commissioner nominee strikes an optimistic note as former FDA heads raise concerns about the decrease in agency credibility during the pandemic.