Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Also, Atlas Venture and Advent France Biotechnology raise new venture capital funds, Corium secures $235m in debt to commercialize ADHD drug and CBMG leads recent VC financings with $120m series A round.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Dunn’s participation at the panel meeting ended speculation that he left the US FDA.