Eli Lilly and Company
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Latest From Eli Lilly and Company
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
The Loxo@Lilly drug got FDA accelerated approval in mantle cell lymphoma as the first non-covalent BTK inhibitor, enabling its use in post-BTKi disease.
The firms’ Orserdu has won a US thumbs up for the treatment of ESR1-mutated advanced or metastatic breast cancer, marking a positive breakthrough for the challenging SERD drug class.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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