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PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational

PNH is a ultra-rare, life-threatening blood disorder in which the immune system destroys red blood cells. The benefits of orphan drug status in the EU include a 10-year

The revefenacin phase 3 program, which includes two replicate efficacy trials and a single twelve-month safety study, is designed to support the product’s registration in the US. Theravance

Afinitor is now approved to treat unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) NET of GI or lung origin in adults with progressive disease. The approval

Ireland-based Jazz will pay $30.25 per share in cash for Celator and get access to Vyxeos, an investigational product in development to treat acute myeloid leukemia (AML). The

It expands the initial EC approval in October 2014 for several patients with CLL. Imbruvica is now available to treat all lines of CLL in the European Union

It is the first deuterated product to be reviewed by the FDA. The agency did not request for new clinical trials. SD-809 (deutetrabenazine) is an investigational, oral, small-molecule

The CHMP recommends the approval of TYSABRI for use as a disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a

AP32788 targets tumors driven by EGFR or HER2 kinases and was designed to achieve selective inhibition of these kinases with exon 20 mutations. There are currently no approved