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The law firm Hagens Berman Sobol Shapiro filed the lawsuit on behalf of Springfield, Missouri, resident Patrick Bills who claims that she developed severe hyperglycemia and new onset

Although the FDA does not have to follow the advice of its regulatory committees, in most cases the agency does. Tysabri is approved for multiple sclerosis, although the

According to Lev, it is the first company to submit a licensing application for the acute treatment of hereditary angioedema (HAE) in the US. The FDA has sixty

Recruitment of the first cohort is expected to be completed within approximately eight months, following which data on the primary endpoints, response rate and safety, will be reported.

The drug, LX211, is a next-generation calcineurin inhibitor intended for the treatment of non-infectious posterior, intermediate and panuveitis (an autoimmune disease characterized by chronic inflammation of the eye).

The company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase III clinical trial involving approximately 270 patients with

Trastuzumab-DM1 comprises ImmunoGen’s cell-killing agent, DM1, linked to Genentech’s HER2-targeting antibody, Herceptin (trastuzumab), and is in development by Genentech for the potential treatment of HER2-expressing metastatic breast cancer.

The drug, LX6171 was well-tolerated at all dose levels and showed excellent systemic exposure, Lexicon said. Over the seven day trial, no dose-limiting toxicities were observed and exposure

Under the terms of the agreement, Crucell will receive an upfront payment, milestone payments, annual maintenance fees, and royalties on net product sales. Other financial details were not