News

Olmutinib is a third-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) intended to treat EGFR mutation-positive non-small cell lung cancer (NSCLC). Boehringer Ingelheim will evaluate

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity

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

"The impact of ABSSSI and CABP among children is significant, as these infections often require hospitalization and are met with limited pediatric treatment options, particularly as resistance increases

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