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The FDA is expected to determine whether to accept the new drug application (NDA) for filing and consider the priority review request within 60 days. If approved, Acura

An agreement via the special protocol assessment (SPA) procedure is an agreement with the FDA that a Phase III clinical trial’s design (endpoints, sample size, control group and

The company noted that certain formalities must be completed before the reissue patent will be granted. The reissued patent will have the same force and effect as the

Mr Caloz joined CytRx in October 2007 and has served as the company’s chief accounting officer. Prior to joining CytRx, he served as CFO of publicly traded Occulogix

For instance, should events warrant, Dor will be eligible to submit a new drug application (NDA) for DOR201 on a rolling basis, permitting the FDA to review sections

Results from the studies in hemorrhoidectomy and in total knee arthroplasty are expected to provide the primary clinical data, in addition to extensive existing preclinical and clinical data,

Emergent will pursue full repayment of the $10 million loan, which is secured by substantially all of Protein Sciences’s assets, and settlement of the outstanding litigation against Protein

Labcoat has developed a novel technology for coating drug-eluting stents that uses precisely metered droplets of a biodegradable polymer and drug formulation to create a thin (

Proceeds from the financing will be used to further develop Anacor’s product pipeline based on its boron chemistry platform. The investments from GlaxoSmithKline (GSK) and Schering fulfill each