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The Phase 1/2 study, taking place at Tampere Hospital in Finland, a world-leading site for celiac disease research, is a two-part (single and repeated administration), double-blind, placebo-controlled, dose

Basilea’s co-development partner Astellas Pharma Inc. also recently submitted a New Drug Application (NDA) for isavuconazole to the U.S. Food and Drug Administration (FDA). Ronald Scott, Basilea’s Chief

Previously, NexoBrid received marketing authorization from the European Medicines Agency for this same indication in the European Union (EU), and the product was commercially launched. "We are especially

ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve

Preclinical studies have shown that IQP-0528 is highly effective against virus strains found throughout the world, prevents HIV transmission in cultured cells, causes sterilization of cultures infected with

The study will engage the laboratory of Dr. Charles Brenner, Roy J. Carver Chair of Biochemistry and Professor of Internal Medicine at University of Iowa. Brenner, is credited

FDA also said that the NDA would be treated as a Class 2 resubmission; hence, the new user fee goal date is 30 December 2014. In April 2014,

The trial is designed to confirm the positive results previously reported for ZS003, a phase III trial in which once-daily doses of ZS-9 maintained potassium levels within the

The sNDA for Olysio and sofosbuvir was submitted in May by the company’s strategic partner Janssen Research & Development. The regulatory submission is based on data from the