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The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which it will give approval for the trial’s design, clinical endpoints and statistical analysis.

Grifols said that approval from the US Food and Drug Administration (FDA) for Flebogamma 10% DIF was obtained in July 2010 and final approval in Europe is expected

With the manufacturing license granted, Hebei Aoxing API Pharmaceucitcal Company submitted business license application, to manufacture Naloxone Hydrochloride API product, to the China Administrative Bureau of Industry and

Cymbalta is marketed by Eli Lilly and Company. Cymbalta is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder, generalised anxiety disorder, diabetic

Abbott‘s Atrasentan Phase 2 study was a double-blind, dose-ranging, placebo-controlled study of subjects with diabetic nephropathy on stable doses of renin-angiotensin system (RAS) inhibitors for more than 2

Par Pharma began shipping 10mg and 20mg strengths of Zafirlukast tablets on 19 November 2010. Accolate, an oral prescription medicine used to treat asthma, works by blocking substances

Azixa is a novel small molecule that acts as a microtubule destabilising agent, causing an arrest of cell division with subsequent programmed cell death, or apoptosis, in cancer

The PTR-35 is designed for vertical mixing applications including hybridisation reactions, cell growing, homogenisation of biological solutions, prevention of blood coagulation and latex diagnostics. The rotator which is

Compugen said that the analysis of the in silico prediction and selection results for the B7/CD28 protein family, the first of three such families selected for validation activities