Go or no go? Abbvie, Roche and Kala await key decisions

After a quiet couple of months the US FDA has a busy August ahead. The agency is set to make approval decisions on up to 11 new projects, according to Vantage’s monthly PDUFA analysis.

The most important of these could concern Abbvie’s rheumatoid arthritis contender upadacitinib. Meanwhile, Roche will be hoping to justify its purchase of Ignyta with a nod for entrectinib, and Kala could get the go-ahead for its lead pipeline asset, the dry eye project KPI-121.