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The agency will review the submission under priority review status which reduces the review time to six months from the standard 10 months. In May 2014, the FDA

These include head and neck, anal, and cervical cancer, as well as anal, vaginal, penile, vulvar and cervical pre-cancerous neoplasias. PDS0101 is based on the company’s proprietary Versamune®

The funding was led by Longitude Capital with participation from OrbiMed, Vivo Capital, CAM Capital, RA Capital Management, Wellington Management, Polaris Partners, Lux Capital and CVF LLC. With

CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma for the US prescription cough-cold market. The first product, Tuzistra XR was approved by the

KAR5585 is being developed for the treatment of pulmonary arterial hypertension (PAH) and other rare diseases marked by extensive fibrosis. KAR5585 is a first-in-class, selective inhibitor of tryptophan

Rociletinib is indicated to treat patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been earlier treated with an EGFR-targeted therapy and

The agency granted Keytruda priority review status with a target action date of 9 August 2016. Keytruda was approved in 2014 to treat melanoma. In October 2015, it

All 29 member states included in the decentralized procedures supported approval of the product. The authorities’ approval formally acknowledges that Synthon’s glatiramer acetate is regarded therapeutically equivalent to

The licensing agreement also encompasses rights for all therapeutic indications to cirmtuzumab, an anti-ROR1 monoclonal antibody that is currently in a clinical trial for patients with chronic lymphocytic