FDA, stop sign

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

Spending time in the sun without protection increases the risk of melanoma, but the potentially deadly skin cancer can occur even on sites with minimal sun exposure, doctors warn.

The U.S. Food and Drug Administration approved Bausch Health Companies Inc.’s topical plaque psoriasis treatment Duobrii, which is expected to be a key revenue driver for the company.

Celgene Corporation announced results from the phase 3 STYLE study, which showed that Otezla (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment response at week 16 compared with placebo.

The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.