Category: North America

FDA approves Cabenuva for some adolescents living with HIV
March 29, 2022 Off

FDA approves Cabenuva for some adolescents living with HIV

By Dino Mustafić

US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

FDA Approves Moderna’s Second Booster
March 29, 2022 Off

FDA Approves Moderna’s Second Booster

By Author

Moderna, Inc. (NASDAQ:MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and adults 18 years of age and older with certain kinds of immunocompromise.

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy
March 29, 2022 Off

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy

By Dino Mustafić

Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) have announced the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone for DMD has been granted Fast Track Designation by the FDA.