The European Medicines Agency (EMA) moved to withdraw the mpox indication for Siga Technologies’ tecovirimat while keeping the drug approved for smallpox, cowpox, and adverse reactions to vaccinia vaccines. The decision follows CHMP review of the antiviral label after its use in patients during recent mpox outbreaks. The outcome highlights how regulators are tightening label scope based on real-world post-outbreak evidence, even when the core product remains within its established indications.