Shots:FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…
Shots:The US FDA approved 11 NDAs & 2 BLAs in December 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023In December 2023, the major highlight drugs were Jaypirca (pirtobrutinib) approved for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, and Iwilfin…
The US FDA approved 4 NDAs and 1 BLA in July 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 42 novel products in 2022In July 2022, the major highlights drugs were Zonisade's approval for partial seizures in adults and pediatric patients with epilepsy, Opzelura (ruxolitinib)…

