Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases
FDA wants another trial in ultra-orphan Barth syndrome, but could not identify a feasible design – so Stealth submitted the NDA anyways, based on a retrospective natural history control trial
You may also be interested in...
Less than two year after going public by a SPAC merger, Gemini will reverse merge with hematology-focused Disc. Bristol Myers Squibb and GentiBio will join forces on Treg development for inflammatory bowel disorders.
Four prominent drug candidates are expecting topline mid- or late-stage data over the next few months. With the help of Biomedtracker's Q2 Outlook Report, we take a look at the assets that could help validate some of the companies developing them, from oncology to psychiatry.
Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker