EC approves Symtuza for HIV-1, Janssen submits NDA to FDA

Johnson & Johnson (NYSE:JNJ) said in September its Janssen Research & Development LLC unit submitted an NDA to FDA for a once-daily fixed-dose combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in patients ages 12 and older.

Also in September, the European Commission approved the combination under the name Symtuza to treat HIV-1 infection in patients ages 12 and older with a body weight of ≥40 kg...