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The Silver Spring, Maryland biotech firm is already in the clinic developing targeted oncology treatments, and now, with the initiation of its first preclinical study that will act

The Phase 2a studies, currently underway at Mayo Clinic and the University of Pittsburgh, are evaluating the hemodynamic effects of AIR001 in both acute and exercise conditions, as

This new batch of RP-323 represents a new second-generation compound with improved product usability and stability. Rich Pharmaceuticals developed the new formulation and all regulatory required testing methods

"This patent significantly expands the strength of the VIMOVO patent estate and extends patent protection out to 2031," said Timothy P. Walbert, chairman, president and chief executive officer,

Teflaro is designed to treat acute ABSSSI caused by susceptible bacterial isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella

The submission is part of the company’s ATX-101 global development program and follows regulatory applications in the US, Canada and Switzerland. In Australia, the regulatory application was supported

An independent data monitoring committee determined that the open-label, multicenter, randomized two-arm trial met its primary endpoint early. Roche chief medical officer and head of Global Product Development

For the sNDA, the anticipated Prescription Drug User Fee Act (PDUFA) action date will be in October 2015. The submission of sNDA was based on data from a

Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone