Merck & Co. said the U.S. Food and Drug Administration will review its application seeking approval of its proposed doravirine/islatravir regimen in certain adults with HIV-1 infection.
Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy.
The Rahway, N.J., drugmaker said the FDA has set a target action date of April 28, 2026, for the application.
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