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Elaprase has previously received fast-track designation from the FDA, and Shire has requested priority review of this submission, which should result in a decision being made by the

“It reflects how far the US has fallen behind its competitors in this pivotal area and how much the lack of federal leadership has handicapped US efforts,” allege

Earlier this year, the American Medical Association’s (AMA) Current Procedural Terminology (CPT) editorial panel established Category I code 87900, described as “infectious agent drug susceptibility phenotype prediction using

Xinhua Finance will give Nutra Pharma strategic advice for advancing its business objectives in China, and help the company to meet potential strategic and operational partners, as well

In the letter, the FDA indicated that at least one additional clinical trial, and a re-read of images obtained in previously completed phase III trials, will be necessary

The decision affirms a lower court decision handed down in March 2005 that immediately halted the sale the generic version by Ranbaxy and Teva, which had launched their

Xyrem was approved by the FDA in October 2002 as a treatment for cataplexy (sudden inability to move) in patients with narcolepsy. The effectiveness of Xyrem for the

New Harbor Corporation (NHC) is to work through PUMC Pharmaceuticals to bring the nitric oxide donor products to market in China that are protected by the Cellegy patent.

Both studies in the clinical program are double-blind randomized, placebo-controlled trials of patients who will receive a brief intravenous infusion of Viprinex or placebo within six hours of