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QIDP status offers for an additional five years of market exclusivity, if approved. Fast Track status provides for more frequent interactions with the FDA review team and a

The definitive pharmacokinetic study and the comparative pain study for the Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector program (Makena SQ) have been initiated with the first patient dosed. The

This recommendation follows the DSMB’s review of the safety data accumulated in the first eight (8) Alström syndrome patients that had received treatment with PBI-4050. The DSMB determined

NovaDerm, which recently received its orphan-drug designation from the FDA, is a regenerative cell therapy that has the potential to re-grow a patient’s own skin in a laboratory

BCD-085 is an innovative drug containing a humanized monoclonal anti-interleukin-17 (anti-IL17) antibody as an active ingredient. The primary objective of the international multicenter double-blind placebo-controlled study is to

RXi is a clinical-stage RNAi firm focused on the development of new therapeutics to solve significant unmet medical needs. As per the deal terms, RXi would issue stock

The aim of the study was to determine the safety and clinical benefit fexapotide can provide to men who were given a second injection of fexapotide for their

The trial showed SUTENT extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of

Following the strategic partnership entered between the two companies in 2014 to combine resources and scientific expertise within dermatology development, the parties have now agreed to fully leverage