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Senate HELP Committee Approves Bill on Ebola Treatments

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The Senate Health, Education, Labor, and Pensions passes a bill designed to help speed the development of treatments and vaccines ...

FDA Denies Kuvan Bioequivalence Petition

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FDA denies a petition to permit a drug company to submit an ANDA demonstrating bioequivalence to BioMarins Kuvan sold in Israel ra...

Mallinckrodt Asks Court to Nix FDA Action on Generic Concerta

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Mallinckrodt asks a Maryland federal court to stop FDA from reclassifying its generic form of Concerta from AB to BX.

Failure to Warn Decision May be Meaningless: Blog

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The Drug and Device Law Blog says a New Jersey court decision allowing a Reglan failure-to-warn claim to go forward will likely no...

Justice Dept. Indicts Vascular Solutions on Unapproved Device

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The U.S. Justice Department files an indictment charging Vascular Solutions and its chief executive officer, Howard Root, with sel...

FDA Partial Hold on CytRx Trials with Aldoxorubicin

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FDA issues a partial clinical hold on CytRx Corp. and its clinical trials for cancer therapy aldoxorubicin have been placed on par...

Novartis Plans Cardiac Drug Application by End of Year

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Novartis says it plans to complete its FDA filing for a new drug to treat heart failure with reduced ejection fraction by the end ...

Respironics Class 1 Recall of Ventilators

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Respironics begins a Class 1 recall of its Esprit V1000 and V200 Ventilators that were installed with third-generation power suppl...

FDA Clears BrainScopes Ahead 100 Brain Injury Evaluator

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FDA approves a BrainScope Co. de novo classification petition allowing the marketing of its Ahead 100 device that uses a patients ...

Public Docket on First Generic ANDA Submissions

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Federal Register Notice: FDA opens a public docket on its proposed criteria for first generic ANDA submissions.