Gamifant for Primary Hemophagocytic Lymphohistiocytosis

The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026.

Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.

This approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home.

Bullous pemphigoid is a rare skin condition that causes large blisters filled with fluids that typically occur near skin creases, such as the upper thighs and armpits.

Alkaptonuria affects approximately 1 in 250,000 to 1 million people in the United States.

The new approval is in line with recommendations that suggest booster vaccination for older adults and patients aged 12 to 64 with at least 1 or more underlying risk factors.