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The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to

Preclinical studies of RAD1901 have shown consistent and robust single agent anti-tumor activity in multiple wild type and ESR1-mutant breast cancer models and tumor regression when combined with

They have entered into an open-access global research partnership with the Structural Genomics Consortium (SGC) to discover and characterise novel drug targets for myeloma. In this first partnership

While there was no statistical difference in viral clearance between treatment and placebo in the overall study population at 12 months, there was a clear separation in 2

This study focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have

Adzenys XR-ODT is bioequivalent to an earlier approved mixed amphetamine salts extended-release capsule (Adderall XR), which the company claims is one of the most commonly prescribed medications to

A proposed interim analysis of the high C-reactive protein (CRP) subgroup showed that ruxolitinib plus regorafenib did not demonstrate a sufficient level of efficacy to warrant continuation. Incyte

The agency granted the treatment priority review with a Prescription Drug User Free Act action date of 23 July 2016. Bezlotoxumab is also under review by the European

The Japan-based company will leverage Medidata’s industry-leading electronic data capture and management technology (Medidata Rave) to evaluate additional indications for OPDIVO, an immunotherapy drug that was initially approved