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FDA Clears 2 New Hitachi Scenaria Models

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FDA clears two Hitachi Medical Systems America Scenaria models of CT scanners.

Forest Asks High Court to Hear Namenda Case

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Forest Laboratories asks the Supreme Court to hear and reverse a 2nd Circuit Appeals Court decision that requires it to continue m...

Panel to Discuss IMPROVE-IT Statins Trial

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FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/14 to discuss the results of the IMPROVE-IT trial, which ...

Dr. Reddys Loses in Court Over Purple Generic Nexium

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A Delaware federal judge issues a temporary restraining order against Dr. Reddys Laboratories blocking the companys sales of a gen...

New Colombia Partners With AiP on Cannabinoid

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New Colombia Resources says it is partnering with Advanced Imaging Projects on developing and accelerating regulatory agency appro...

Qualified Infectious Disease Product Status for Destiny Drug

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FDA grants Destiny Pharma a Qualified Infectious Disease Product designation for the XF-73 (exeporfinium chloride) and its use in ...

Panel to Review Merck NDA Supplements for Ezetimibe

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee plans to review Mercks IMPROVE-IT trial and its support of supplemental...

NeuroDerm Modifies Parkinsons Trials After FDA Feedback

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NeuroDerm modifies its U.S. development plan for ND0612H and ND0612L, the companys continuous, subcutaneously delivered levodopa/c...

Neos Complete Response Seeks Additional Data on ADHD Drug

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FDA issues Neos Therapeutics a complete response letter on the companys NDA for Cotempla XR-ODT (methylphenidate extended release ...

FDA Clears Deerfield Imaging Brain Biopsy System

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FDA clears a Deerfield Imaging 510(k) to market its SYMBIS stereotactic brain biopsy system in the U.S.