Priority review designation essentially fast tracks the approval process for investigational agents that address unmet medical needs. Based on this designation, the FDA reviews the application with a
The committee voted ten to three to recommend the drug to be used in combination with gemcitabine in patients who have not received previous chemotherapy. Tarceva, which is
The trial, to be conducted in 73 centers around Europe, will investigate the safety and efficacy of Alzhemed in treating Alzheimer’s disease, with some 930 mild-to- moderate Alzheimer’s
It was expected that Oporia would be a big selling drug for Pfizer with annual sales estimated up to $1 billion. The application for Oporia, a selective estrogen
The drug produced a significant improvement in blood pressure and arterial stiffness in patients at risk of cardiovascular events such as heart attack and stroke, but with no
The advisory committee chose not to recommend Xinlay (atrasentan) for the treatment of patients with hormone-refractory prostate cancer (HRPC) that has spread to the bone but did say
Mouse Specifics analyzed the gait of animals with Parkinson’s disease, Huntington’s disease, and amyotrophic lateral sclerosis (ALS) using a high speed digital imaging system. Mice were placed on
Until recently, intrauterine devices (IUD) were only recommended for women in mutually monogamous relationships with at least one child. Now, the FDA has approved the hormone-free ParaGard as
Aromasin (exemestane) is a hormonal therapy, used to treat women with breast cancers that depend on a hormone, specifically estrogen, for growth and survival. An estimated two-thirds of
Initially, the companies will focus on Novavax’s H9N2 avian flu virus-like particle vaccine that has shown promising results in preclinical studies. Wave Biotech will provide process and equipment
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