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In May 2017, the FDA turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus. During that time, the companies received a complete response letter from the FDA.

The company said that it has received final minutes from a February 2018 Type C meeting held with the Division of Neurology Products, United States Food and Drug

This exploratory analysis from the CANVAS Program was featured as a late-breaking oral presentation at the American College of Cardiology’s 67th Annual Scientific Session (abstract #407-10) and was

PF-04958242, which is ready for phase 2b development, is an AMPA receptor potentiator, developed for treating cognitive impairment associated with schizophrenia (CIAS). AMPA receptors restore excitatory synaptic transmission process

This team brings together Covance’s operational expertise in flow cytometry, immunoassays and cell-based assays with its scientific expertise in immunotoxicology study design, direction and operation to provide a

Investors in the round included OrbiMed, Pontifax Fund, RA Capital Management, EcoR1 Capital, Omega Funds, BVF Partners L.P., Boxer Capital, LLC, Adage Capital Management L.P., and Alexandria Venture

The Odyssey Outcomes trial, which met its primary endpoint, was held in nearly 19,000 patients who had a recent acute coronary syndrome (ACS) event, such as a heart

Tofacitinib is a Janus kinase (JAK) inhibitor, which is yet to secure approval for the treatment of UC. The FDA and the European Medicines Agency (EMA) are currently reviewing the

The Type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which demonstrated that patients with adequately controlled asthma were able to