New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

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.

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.