FDA Holds Up Centocor’s Ustekinumab Three Months But Wants No New Trials
This article was originally published in The Pink Sheet Daily
Executive Summary
PDUFA date stalled so agency can review BLA amendments.
You may also be interested in...
FDA To Centocor: Show Me The REMS
Ustekinumab “complete response” letter requests medication guide and communication plan, but not restricted distribution.
FDA To Centocor: Show Me The REMS
Ustekinumab “complete response” letter requests medication guide and communication plan, but not restricted distribution.
J&J’s Stelara Beats Enbrel In Psoriasis
New survey shows doctors are warming to another rival, Humira.