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The projected FDA’s action date is 11 November, while the EMA's centralized review process is underway. The data supporting both applications were generated in the phase 3 Checkmate-141

The objectives of the trial are to demonstrate: 1. IntelGenx oral film product will provide therapeutically effective blood levels of montelukast, and; 2. montelukast when delivered using IntelGenx

The randomized, double-blind, placebo-controlled study will enroll approximately 70 healthy volunteers to evaluate the safety and tolerability of NYX-2925 at multiple doses. The study will include both single-dose

The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab. Under the terms of the agreement, Amgen will remain responsible for the development

Developed in the lab of Professor Edward Schuchman, PhD, at the Icahn School of Medicine at Mount Sinai, rhAC showed promising results in a mouse model of Farber

The new collaboration on a phase 1b study will assess the safety and tolerability of Lilly's cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor abemaciclib (LY2835219) in combination

CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma ("Tris") for the US prescription cough-cold market.  The first product, Tuzistra XR was approved by the FDA in April 2015 and was

BioInvent president and CEO Michael Oredsson said: “The agreement with Alligator to manufacture its new bispecific antibody ADC-1015 speaks to our leading expertise when it comes to manufacturing of antibodies.

Pfizer said that the S-TRAC study was the first RCC trial of a tyrosine kinase inhibitor (TKI) to extend DFS in the adjuvant setting. The adjuvant therapy intends