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The study was co-written by Dr David Graham, one of the FDA’s own scientists and a long-time critic of COX-2 inhibitors such as Merck & Co’s Vioxx and

SOT-107, licensed from Xenova Group, is being developed by Sosei initially for the recurrent form of this brain tumor. The medical need for improved treatment of this disease

This acceptance for filing indicates that the new drug application (NDA) is sufficiently complete to permit a substantive review of the data supporting Xinlay’s safety and effectiveness. Abbott’s

Tev-Tropin (somatropin (rDNA origin) for injection) was clinically tested and FDA-approved for growth hormone deficiency (GHD), and is manufactured by Savient using recombinant DNA (rDNA) technology. Teva has

The study is designed to assess the clinical benefit of using TNFerade in combination with the standard of care treatment. In October 2004, the FDA placed the TNFerade

As part of that decision, Amgen has also concluded that it will not provide GDNF (glial-cell-lined-derived neurotrophic factor) to the 48 patients who participated in clinical trials that

The blinded, placebo-controlled 60-patient study, named “La Plata”, showed a statistically-significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction (LVEF). Following 28 days

Pursuant to the settlement, Alpharma has waived its FDA-awarded 180-day marketing exclusivity, enabling Ivax to begin selling gabapentin capsules from March 23, 2005 and gabapentin tablets from April

In the study, Zomig nasal spray (zolmitriptan) provided significant migraine headache response and pain-free rates as early as 15 minutes post-dose in migraine sufferers, with significantly higher sustained