Latest News in the pharma Industry

Policy & Regulation

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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ICH Reviews Future ICH Topics and its Organisation

ICH Reviews Future ICH Topics and its Organisation

11 Dec 2013

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China Finally Allows FDA To Add Inspectors

China Finally Allows FDA To Add Inspectors

9 Dec 2013

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Risk Assessment for Ascertaining GMP for Excipients

Risk Assessment for Ascertaining GMP for Excipients

5 Dec 2013

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Rx-360 Applauds Passage of Drug Quality and Security Act

Rx-360 Applauds Passage of Drug Quality and Security Act

29 Nov 2013

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FDA Warning Letter Statistics 2013 Regarding Process Validation/Qualification/Calibration

FDA Warning Letter Statistics 2013 Regarding Process Validation/Qualification/Calibration

28 Nov 2013

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FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release Tablets

FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release Tablets

27 Nov 2013

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