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A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA requested additional

Crown Bioscience president Jean-Pierre Wery said: "Crown’s suite of in vitro and in vivo immuno-oncology assays employing translational experimental models help inform and accelerate the development of cancer

A total of 117 patients were enrolled at over 20 sites in the US and Canada for the company’s PUNCH CD 2 multi-center, randomized, double-blind, placebo-controlled trial to

Novartis unit Sandoz is seeking approval for the similar indication as the reference product. The company said the totality of evidence in its submission, including three clinical trails,

Avelumab, also known as MSB0010718C, inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system. It is believed to engage the innate immune

Farletuzumab is an investigational humanized monoclonal antibody (mAb) that binds to folate receptor alpha, a protein which is highly expressed in ovarian carcinoma but largely absent from normal

Cebranopadol is a novel, first-in-class analgesic in development for the treatment of moderate to severe chronic nociceptive and neuropathic pain and is an important addition to Depomed’s leading

The acquisition bolsters LGC’s growing portfolio of reference materials and proficiency testing (PT) schemes for the clinical market. LGC’s Standards Division managing director Euan O’Sullivan said: "We are

The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with