As­traZeneca’s Ul­tomiris la­bel ex­pan­sion stalls af­ter FDA re­jects sBLA, asks for REMS changes

As­traZeneca’s rare dis­ease as­set Ul­tomiris was pre­sent­ed with a CRL for neu­romyelitis op­ti­ca spec­trum dis­or­der (NMOSD), as the FDA seeks tweaks to the mon­o­clon­al an­ti­body …

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.