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GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities for the benefit of global generic drug providers and US generic drug users, in

Olesoxime (TRO19622) is the lead compound of the Trophos’ proprietary cholesterol-oxime compound family of mitochondrial pore modulators. The 24-month randomized, parallel group, double-blind, placebo controlled trial will compare

In return for the license, Colby will pay to Juvaris cash, development-related milestones and royalties on product sales. In addition, Colby will bear all development and commercialization-related expenses

IBM will develop the base Watson healthcare technology on which WellPoint’s solution will run. Watson, named after IBM founder Thomas Watson, is a computing system that is designed

The company has developed the SMS to programmatically populate and update the patient information and visit schedule to reduce site workload and improve adoption rates throughout the study.

Everolimus treats patients aged 3 years and older who require therapeutic intervention but are not amenable to surgery. Everolimus targets mTOR, a protein that acts as a regulator

Sucampo will have exclusive commercial rights to any biologic products successfully developed and commercialized in the course of the collaboration. The agreement allows Numab to receive up to

The funding will be used in multiple animal efficacy studies as well as human safety studies to further demonstrate the utility of Anthim (ETI-204), to prevent disease and

The double-blind, dose-ranging, multi-center, parallel group, randomized study was designed to evaluate the safety and efficacy of taliglucerase alfa in 31 treatment-naive patients suffering from Gaucher disease. Patients