Twelve applications with September goal dates include six novel agents but only one breakthrough designation.

The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.

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.

The Israeli firm Gamida Cell’s lead candidate has obtained a US approval as a new donor source for allogeneic stem cell transplant with the chips in place for independent commercialization despite its recent financial troubles.