China's Dizal has won the first approval worldwide, in its home market, for a JAK1 inhibitor in relapsed/refractory peripheral T-cell lymphoma (PTCL), based on a pivotal Phase II trial. The biotech is also planning a Phase III study with the molecule for second-line PTCL.

CBER's Lola Fashoyin-Aje offers some thoughts on when and how the FDA might consider the accessibility of a product in its approval decisions at BIO 2024.

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.