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Florida Shuts Down Monoclonal Antibody Treatment Sites After FDA Revokes Authorization

florida-shuts-down-monoclonal-antibody-treatment-sites-after-fda-revokes-authorization

All state-run monoclonal antibody treatment sites in Florida are being shut down after U.S. drug regulators revoked emergency use authorization for the two most widely used monoclonals. The Food and Drug Administration’s (FDA) move banned, at least for now, the use of monoclonals produced by Regeneron and Eli Lilly. The regulator said the most recent information and data showed the treatments are “highly unlikely” to work against the Omicron variant of the CCP (Chinese Communist Party) virus and the drugs can only be used on patients who are likely to have been infected or exposed to a different variant. Because Omicron is dominant nationwide, the antibodies cannot be used anywhere in the United States at this time. The FDA did not provide citations for the data in a press release, updated fact sheets for health care providers, or letters to the companies. An agency spokesperson did not respond to requests for comment and …  » Read full article

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