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FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the company has

The company will open the IND with two identical registration quality Phase III studies. The work has been awarded to an appropriate CRO. This IND is based on

The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. According to the company, JIA is

Pursuant to the proposed amendment, the number of shares of Oracle common stock used in the calculation of the exchange ratio pursuant to which shares of PTI common

The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52% reduction in the risk of

The potency, tolerability, pharmacokinetic and pharmacodynamic properties of NXD30001 and its derivatives indicate that it, or an analog, may be useful in the treatment of breast and other

The decision was made in response to recent reports related to additional events identified in a cohort of volunteers in a safety study involving the drug. The decision

The Recovery trial is a single-blinded, randomized trial that compared the ClosureFAST catheter with endovenous laser ablation in 62 limbs. Dr. Proebstle of Heidelberg, Germany, said: “Our study

The trial was designed to evaluate the effect of MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal myocardial infarction up to and including 30 days