This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

US FDA approval in IgAN is just the first step in a much larger renal disease strategy for the company, which includes additional kidney indications for Fabhalta.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Private Company Edition: After its acquisition by an investor earlier this year, NGM Bio has raised a $122m series A round, adding to a recent surge in large venture capital financings. Also, Vanqua Bio disclosed $45m in new funding and Renalys completed a $38.4m series A.