Latest News in the pharma Industry

Policy & Regulation

Merck Statement on FDA Advisory Committee Meeting for RAGWITEK, an Investigational Sublingual Allergy Immunotherapy Tablet

Merck Statement on FDA Advisory Committee Meeting for RAGWITEK, an Investigational Sublingual Allergy Immunotherapy Tablet

29 Jan 2014

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Novartis to Request Re-Examination of Serelaxin in Acute Heart Failure for Conditional Marketing Authorisation in EU

Novartis to Request Re-Examination of Serelaxin in Acute Heart Failure for Conditional Marketing Authorisation in EU

27 Jan 2014

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FDA Prohibits Ranbaxy’s Toansa, India Facility from Producing and Distributing Drugs for the US Market

FDA Prohibits Ranbaxy’s Toansa, India Facility from Producing and Distributing Drugs for the US Market

27 Jan 2014

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Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket?

Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket?

24 Jan 2014

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USP Proposal on Temperature Control During Storage and Distribution

USP Proposal on Temperature Control During Storage and Distribution

10 Jan 2014

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Daclatasvi?r Marketing Authorizat?ion Applicatio?n for Treatment of Chronic Hepatitis C Validated for Accelerate?d Regulatory Review by EMA

Daclatasvi?r Marketing Authorizat?ion Applicatio?n for Treatment of Chronic Hepatitis C Validated for Accelerate?d Regulatory Review by EMA

10 Jan 2014

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Merck Receives FDA Approval for Isentress (Raltegravir)

Merck Receives FDA Approval for Isentress (Raltegravir)

9 Jan 2014

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Genzyme Receives Complete Response Letter from FDA  on Lemtrada (Alemtuzumab) Application

Genzyme Receives Complete Response Letter from FDA on Lemtrada (Alemtuzumab) Application

2 Jan 2014

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FDA Approves Tretten to Treat Rare Genetic Clotting Disorder?

FDA Approves Tretten to Treat Rare Genetic Clotting Disorder?

24 Dec 2013

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FDA Requires Multiple New Safety Measures for Leukemia Drug Iclusig; Company Expected to Resume Marketing?

FDA Requires Multiple New Safety Measures for Leukemia Drug Iclusig; Company Expected to Resume Marketing?

23 Dec 2013

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Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract)

Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract)

13 Dec 2013

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FDA Advisory Committee Votes on Investigational Medicine Metreleptin

FDA Advisory Committee Votes on Investigational Medicine Metreleptin

12 Dec 2013

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