Regulation

<div class="articleContainer"><div class="articleWrapper"><div class="articleContent"><h1 class="text title">Reversing course, Gilead asks FDA to rescind remdesivir&apos;s Orphan designation</h1><h2 class="title-bottom webtitle">BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.</h2><div class="byline">Elizabeth S. Eaton, Staff Writer</div><div class="date"></div></div></div></div>

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

Gilead Sciences Inc.

Two days after receiving Orphan Drug designation for its COVID-19 therapeutic, Gilead has asked FDA to rescind the status and said it would waive &#x201c;a...

cov19pol

cov19count

remdesivir, GS-5734

Reversing course, Gilead asks FDA to rescind remdesivir's Orphan designation

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.