Gilead resubmits marketing application to the FDA for HIV drug lenacapavir
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Gilead Sciences (NASDAQ:GILD) said on Monday it had resubmitted its marketing application to the U.S. Food and Drug Administration for lenacapavir to treat HIV-1 infection in people with multi-drug resistant.

In Feb, the FDA issued Gilead a complete response letter (CRL) for its New Drug Application for lenacapavir over the container vial for use with the drug.
The FDA had cited borosilicate glass and its compatibility with lenacapavir solution as the reason for the CRL.
Lenacapavir is an investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.