Keeping Track: New Formulations Dominate In CNS; Immunocore Brings First TCR Therapy To US FDA

Impel NeuroPharma, Inc.’s Trudhesa nasal spray for migraine and Johnson & Johnson’s once-every-six-months injectable antipsychotic Invega Hafyera stood out in a quiet week for approvals at the US FDA, while Teva Pharmaceuticals USA Inc. submitted a long-acting formulation of a different injectable antipsychotic, risperidone, and Supernus requested an adult indication for its non-stimulant ADHD drug Qelbree.

New applications were submitted for one very common condition – H. pylori infection, treated by Phathom Pharmaceuticals, Inc.’s vonoprazan...