Novartis Zelmac Study In 1,500 Women Will Address FDA Data Request
This article was originally published in Pharmaceutical Approvals Monthly
Novartis’ ongoing study of Zelmac in 1,500 women with constipation-predominant irritable bowel syndrome "should provide ample additional data to address [FDA’s] request" for further information on the drug, the company said.
You may also be interested in...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class