Novartis Awaits FDA Action On Aclasta After “Approvable” Letter For Paget’s Disease
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis is waiting to hear back from FDA on the status of zoledronic acid for the treatment of Paget's disease of the bone after responding to an "approvable" letter from the agency
You may also be interested in...
Novartis Foresees Aclasta Approval By Year-End Despite Second "Approvable" Letter
FDA is seeking additional information from ongoing osteoporosis trials of the zoledronic acid for treatment of Paget's disease.
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.