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Xyrem (sodium oxybate) oral solution, CIII, is indicated to treat cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in narcolepsy. The drug is the

The company plans to follow up by submitting a briefing package on a later date in support of a pre-IND meeting to review the company’s proposed strategy and

The company has also completed a Phase II trial of ZP-PTH to treat severe osteoporosis as well as intends to carry out Phase III development. As part of

Since 1998, Priftin has been approved in combination with one or more antituberculosis drugs, to treat active pulmonary TB caused by Mycobacterium tuberculosis. The approval was based in

AnaptysBio and TESARO first initiated their collaboration in March of 2014, and have together focused on the development of monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1

This collaboration integrates the Flatiron Health OncologyCloud™ platform with Foundation Medicine’s comprehensive genomic profiling capabilities to support evidence-based drug development and help accelerate the delivery of safe, effective

Funding for this activity will be provided through a Small Business Innovation Research (SBIR) contract. Process development will focus on optimization of growth and yield of the virus

Within the past 18 months, Qualitas Health has completed all necessary stages of product development through commercialization, including research and development, performing clinical studies, protecting intellectual property, obtaining

Background The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions, follows a 2013 warning by FDA that the drugs are