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FDA believes that the PreGen-Plus assay is a medical device requiring pre-market approval or clearance. Jeffrey Luber, president of Exact Sciences, commented: “Having spoken with the FDA regarding

The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic breast cancer resistant to treatment with an anthracycline, and

The two Phase III pivotal trials assessed the safety and efficacy of a six-month course of Puricase therapy in patients with treatment-failure gout, under the auspices of a

The agreement has an initial five-year term that can be terminated earlier by either party on six months notice and automatically renews for successive two-year terms unless terminated

For the option, Cubist will pay $4.7 million and also will pay approximately $1 million for Illumigen’s operating costs during the option period and for an IND-enabling study

A total of 41,509,214 common shares were deposited by shareholders of Orthosoft. This represents, with shares held by Zimmer or its affiliates, 91.31% of the 52,392,755 outstanding Shares.

Isis has granted an exclusive worldwide license to Altair for the development and commercialization of ISIS 369645, an inhaled inhibitor of the IL-4/IL-13 signaling pathways for the treatment

Consummation of the transaction remains subject to customary closing conditions, including clearance from antitrust authorities in Portugal and Turkey. The initial review periods in both of these jurisdictions

The iX range of afterloaders will be officially introduced at the annual American Society of Therapeutic Radiation Oncologists exhibition in Los Angeles on October 29, 2007. At the