Restructuring Edition: Impel eliminated R&D spending earlier this year to focus on Trudhesa commercialization, but is examining all options, including bankruptcy, as its funding runs out. Also, Alaunos, BioXcel and others announce job cuts and strategic shifts during second quarter updates.

Galera's stock has cratered after the US FDA issued a complete response letter for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer.

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.