An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
Encouraging cholangitis data follows the lifting of a clinical hold on Cymabay’s seladelpar, signalling a way forward for a project that looked finished.
Global drug stocks enthusiastically joined the recovery on the financial markets in the second quarter, more than offsetting earlier declines.
Biopsy data set up efruxifermin as a strong contender in the race to find an effective Nash treatment.
The company blasts the US regulator as weeks of uncertainty for its lead drug in Nash end in a complete response letter.
Inventiva’s mid-stage win has revived hopes for PPAR agonists in the liver disease, although safety questions remain.
June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Five years after failing phase II in Nash, elafibranor fails phase III in Nash; a focus on liver cirrhosis beckons.