FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD - Drug Topics
FDA grants EUA to Novavax's updated COVID-19 vaccine for individuals aged 12+, available in U.S. pharmacies. FDA clears first digital therapeutic, DaylightRX, for GAD treatment. Embecta receives 510(k) clearance for disposable insulin patch pump for T1D and T2D patients. FDA authorizes BioVie's IND for phase 2 trial of bezisterim to treat neurological symptoms of post-COVID-19 condition.
Reference News
FDA grants EUA to Novavax's updated COVID-19 vaccine for individuals aged 12+, available in U.S. pharmacies. FDA clears first digital therapeutic, DaylightRX, for GAD treatment. Embecta receives 510(k) clearance for disposable insulin patch pump for T1D and T2D patients. FDA authorizes BioVie's IND for phase 2 trial of bezisterim to treat neurological symptoms of post-COVID-19 condition.