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11/20/09 - Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent

Boston Scientific Corporation today announced that it has received 510 clearance from the U.S. Food and Drug Administration and CE Mark approval to market its WallFlexÂ® Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer.

11/20/09 - FDA Approves Intravenous Formulation Of Pfizerâ??s RevatioÂ® (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Revatio is the Only Treatment in Its Class with Both Oral and Intravenous Formulations. Pfizer announced today that the U.S. Food and Drug Administration has approved Revatio Injection, an intravenous formulation of Revatio. Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension to improve exercise ability and

11/20/09 - Food and Drug Administration Documents and Publications

Guidance for Industry on Changes to Approved New Animal Drug Applications--New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability. SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry #191 entitled "Changes to Approved NADAs--New NADAs vs.

11/19/09 - Astellas and XenoPort Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application has been filed with the Pharmaceuticals and Medical Device Agency in Japan for ASP8825, also known as XP13512, as a potential treatment for restless legs syndrome. "We are pleased to submit the NDA for ASP8825 in Japan," said Masafumi Nogimori, Astellas' president a

11/19/09 - Doctors Research wins FDA clearance for Kryptonite bone cement

Doctors Research Group, a biomedical company, has received the FDA's 510 approval to market Kryptonite bone cement for cranioplasty applications.

11/19/09 - Endologix gets FDA approval for percutaneous EVAR pivotal study

19 November 2009 - Endologix Inc, a US-based maker of minimally invasive treatments for aortic disorders, said yesterday it has obtained Investigational Device Exemption conditional approval from the US Food and Drug Administration to start a study for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair utilising its

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