FDA Approves Pneumococcal 15-Valent Conjugate Vaccine for Pediatric Use
On June 22, 2022, Merck announced that the FDA approved an expanded indication for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children aged 6 weeks through 17 years. Vaxneuvance is now indicated for active immunization for the prevention of invasive disease caused by specific serotypes of Streptococcus pneumoniae. The approval follows the FDA's Priority Review of Merck's supplemental application. Read more.
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FDA Approves Qsymia for Weight Management in Pediatric Patients
On June 27, 2022, the FDA approved the supplemental New Drug Application for Qsymia (phentermine and topiramate extended-release capsules) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with a BMI in the 95th percentile or greater, standardized for age and gender. Read more.
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