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REMS resubmission delays Truvada in PrEP by 3 months

This article was originally published in Scrip

Executive Summary

A submission earlier this month of an updated risk evaluation and mitigation strategy (REMS) plan has postponed the US FDA's decision about whether it will permit Gilead Sciences to market its drug Truvada (emtricitabine/tenofovir disoproxil fumarate) as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults.



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