Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.
The US FDA gave its blessing to Valeant Pharmaceuticals International Inc.'s psoriasis treatment Siliq (brodalumab), but without a four-letter suffix the agency said it would require for novel biologics and biosimilars.
A monoclonal antibody, brodalumab was approved Feb. 15 for the treatment of adults with moderate to severe plaque psoriasis. The...
The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.
The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.
The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.
