Incyte reported positive topline Phase III results for Monjuvi in relapsed or refractory follicular lymphoma and plans to file for US FDA approval by the end of 2024.

US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.

Sumitomo’s novel AML candidate has shown early clinical promise and been granted US Fast Track status for a form of AML, which looks set to aid the Japanese firm's strategic shift to oncology following recent CNS setbacks.