FDA Refuses ARCA' NDA On Gencaro, Seeks Additional Trial (Pharmaceutical Business Review)
ARCA biopharma has received complete response letter from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval for Gencaro (bucindolol hydrochloride). FDA has stated that it cannot approve the NDA in its current form and specified additional actions and information. The drug is meant for the treatment of chronic heart failure.

Pfizer Discontinues Sunitinib Plus Paclitaxel Trial (Pharmaceutical Business Review)
Genzyme is all set to market and sell Campath MabCampath (alemtuzumab), Fludara (fludarabine) and Le ... GlaxoSmithKline has announced that the US Food and Drug Administration (FDA) has approved Lamictal X ...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan ... (PR Newswire via Yahoo! Finance)
This month's Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma's L-CsA, inhaled liposomal cyclosporine A.