A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

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.

Sanofi consumer health scientific affairs lead moves to CHPA; change in Bayer’s US consumer health marketing helm; Viatris CCO moves from same post at Moderna; Qnovia expands scientific advisory board; and Powerade powers Girls Inc. scholarships, programs.