Gilead faces a hur­dle in its race for big, add-on OK for De­scovy as gener­ic Tru­va­da ri­vals loom

The FDA’s Ad­Com for a po­ten­tial­ly block­buster sup­ple­men­tal ap­proval on Gilead’s De­scovy open­ing the door for its use to re­duce the risk of HIV in­fec­tion is like­ly to get down to this: Just how broad should the la­bel be in iden­ti­fy­ing the right pa­tient pro­file? 

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