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This benefit is also supported by trials such as LEADER, SUSTAIN-6, and EXSCEL, in which the reduction in MACE was significant among those with established ASCVD

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Coming on the heels of the Hims & Hers confrontation and the September 2025 cease-and-desist campaign, these letters establish a clear trajectory: the FDA intends to use the full range of its enforcement authority to curtail what it views as misleading marketing of compounded drugs that circumvent the approval process

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