Business, energy, technology, markets and global industry news from Business News Today

supplemental New Drug Application

Pharma & Biotech

Could Arcutis Biotherapeutics unlock the next big pediatric dermatology gap with Zoryve?

Arcutis Biotherapeutics has secured U.S. Food and Drug Administration acceptance of its supplemental New Drug Application for Zoryve roflumilast cream 0.05 percent to expand treatment of mild to moderate atopic dermatitis to infants aged 3 to 24 months. The filing moves the steroid-free topical therapy into a regulatory review with a target action date of

Read More
Pharma & Biotech

Why the FDA hearing on Vanda Pharmaceuticals’ HETLIOZ could reshape drug approval challenges

FDA grants rare hearing to review Vanda Pharmaceuticals’ HETLIOZ jet lag application. Discover what this regulatory fight could mean for circadian medicine.

Read More
Pharma & Biotech

Biofrontera targets U.S. label expansion for Ameluz in trunk and extremities

Phase 1 PK data bring Ameluz closer to broader FDA review. Explore the regulatory stakes and market impact in actinic keratosis.

Read More