Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

User fee goal dates in the second half of 2023 suggest cancer and breakthrough therapy approvals should recover from first-half dips and a resumption of inspections in China could revive COVID-delayed products.

Kinnate presented early monotherapy and combination data for its pan-RAF inhibitor at AACR, but its prioritization of BRAF Class II drew analyst concerns that its focus might be too narrow.

The DREAMM-3 study was meant to be a confirmatory study for Blenrep, and its failure raises concerns over its use in earlier lines of therapy and the possibility that it could be removed from the market.