The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

PureTech’s LYT-100 has failed to show benefit over placebo in long COVID, and raised doubts about how treatable the condition is – in contrast to the drug’s other potential use in idiopathic pulmonary fibrosis.

Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.

Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.