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We observed a fantastic effect after a single injection," says Tomas Cihlar, senior vice president of virology at Gilead

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Food and Drug Administration and European Medicines Agency require comprehensive data on pharmacology, toxicology, and manufacturing quality (Hasegawa et al., 2021)

As we stated in the CY 2020 PFS final rule, we also continue to believe that limiting the payment amount to 100-percent of the volume-weighted ASP for a HCPCS code will incentivize the use of the most clinically appropriate drug for a given patient (84 FR 62651 through 62656)