12:00 AM
 | 
Oct 07, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Obeticholic acid regulatory update

Intercept said it plans to submit by the end of next year an NDA seeking accelerated approval to FDA and an MAA to EMA for obeticholic acid to treat primary biliary cirrhosis (PBC). Intercept said the NDA will be based on the use of the primary endpoint of the...

Read the full 224 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >