Gilead Sciences, Inc.

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Gilead Resubmits New Drug Application To U.S. Food And Drug Administration For Lenacapavir, An Investigational, Long-Acting HIV-1 Capsid Inhibitor

Published: 06/27/2022 21:24 GMT
Gilead Sciences, Inc. (GILD) - Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-acting Hiv-1 Capsid Inhibitor.
Gilead Sciences Inc - NDA Resubmission Addresses Issues Related to Vial Compatibility.
Gilead Sciences Inc - Once Accepted by FDA, a New Prescription Drug User Fee Act (pdufa) Date Will Be Established.
Gilead Sciences - Resubmission Contains Cmc Data to Support Compatibility of Lenacapavir With Alternative Vial Type Made From Aluminosilicate Glass.