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The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate the development and expedite the review of drugs that are intended to

The MAA filing was based on data from the company’s completed phase 2 study. During the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the

Erenumab, which is being co-developed with Novartis, was tested at the 70 mg and 140 mg doses in a 12-week, 667-patient phase 2 study of subjects who were

Under the partnership, Ultragenyx will receive an exclusive license to one preclinical Takeda candidate in an unspecified predetermined area of use. Ultragenyx will retain an exclusive option to

Sirukumab is being co-developed by GlaxoSmithKline (GSK) and Janssen Biologics in a partnership that startesd in December 2011. It is a human monoclonal IgG kappa antibody that binds

"The preclinical data we presented at ASH in December 2015 supported the evaluation of M281 as a strategy for the rapid and reversible suppression of pathogenic autoantibodies or

The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling

Each unit consists of (i) one share of Pieris’ common stock or non-voting series A convertible preferred stock convertible into one share of common stock, (ii) 0.40 warrants

Over three years, Adimab will use its proprietary, yeast-based discovery platform to generate IgGs or bispecifics for development as therapeutic products for multiple targets chosen by Innovent. Innovent