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

The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.

Santhera is bouncing back after a Duchenne drug failure two years ago with idebenone, and is looking to gain approval of vamorolone in this indication as well as the much rarer Becker muscular dystrophy.

With India’s first and the world’s third mRNA vaccine, Gennova plans to provide access to its COVID-19 vaccine to those deprived of doses from Pfizer and Moderna. HDT Bio Corp’s suit in the US is not seen impacting marketing plans in India, COO tells Scrip