The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
In a week without US novel approvals, a nearly 10-year-old combination of targeted oncology drugs took the spotlight when Novartis AG's Tafinlar/Mekinist received the Food and Drug Administration’s sixth tumor-agnostic drug approval in five years.
Novel agents were more plentiful on the submission side. The new new drug applications included two non-hormonal drugs waiting to...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
