The sNDA is supported by data from the phase 3 CANDLE study.
The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a 2-dose primary series (0.5mL each), separated by 3 weeks.
The biomarker test measures NfL levels through standard blood collection.
First Relief is a wearable PENS device that is placed behind the ear.
The approval was based on data from a phase 3 trial which included 2260 adolescents 12 to 15 years of age enrolled in the United States.
If approved, Opill would be the first OTC oral contraceptive pill available without a prescription.
Two Omicron-adapted Pfizer-BioNTech COVID-19 vaccine candidates elicited strong immune responses vs the current COVID-19 vaccine.
The approval was based on data from a phase 4 study which included patients 12 to 17 years of age with a BMI at the 95th percentile or greater standardized for age and sex.
The USPSTF reviewed 17459 unique citations and 379 full-text articles to assess the benefits and harms of vitamin and mineral supplementation in healthy adults.
For children, Vaxneuvance is administered as a 4-dose series at 2, 4, 6 and 12 through 15 months of age (and at least 2 months after the 3rd dose).
