Latest News in the pharma Industry

Policy & Regulation

Sprout Pharmaceuticals Receives FDA Approval of Addyl (Flibanserin 100 MG)

Sprout Pharmaceuticals Receives FDA Approval of Addyl (Flibanserin 100 MG)

19 Aug 2015

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Seattle Genetics Announces FDA Regular Approval of Adcetris (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients

Seattle Genetics Announces FDA Regular Approval of Adcetris (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients

18 Aug 2015

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Endo Announces US District Court Ruling Upholding Opana ER Intellectual Property

Endo Announces US District Court Ruling Upholding Opana ER Intellectual Property

17 Aug 2015

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FDA Approves US Product Labeling Update for Sprycel (Dasatinib)

FDA Approves US Product Labeling Update for Sprycel (Dasatinib)

14 Aug 2015

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Successful Sterile Inspection for Scottish CMO

Successful Sterile Inspection for Scottish CMO

10 Aug 2015

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Prevnar 13 Now Approved in Canada for the Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults Aged 18 Years and Older

Prevnar 13 Now Approved in Canada for the Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults Aged 18 Years and Older

5 Aug 2015

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FDA Final Rule Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

FDA Final Rule Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

3 Aug 2015

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Catalent's OptiShell Technology is Delivery Platform for OPKO Health's New Chronic Kidney Disease Treatment

Catalent's OptiShell Technology is Delivery Platform for OPKO Health's New Chronic Kidney Disease Treatment

3 Aug 2015

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FDA Naming Guidance of Drug Products Containing Salt Drug Substances

FDA Naming Guidance of Drug Products Containing Salt Drug Substances

29 Jul 2015

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Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

28 Jul 2015

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Regeneron and Sanofi Announce FDA Approval of Praluent Injection, the First PCSK9 Inhibitor in the US, for the Treatment of High LDL Cholesterol in Adult Patients

Regeneron and Sanofi Announce FDA Approval of Praluent Injection, the First PCSK9 Inhibitor in the US, for the Treatment of High LDL Cholesterol in Adult Patients

27 Jul 2015

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Merck Announces EMA Acceptance of Marketing Authorization Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection

Merck Announces EMA Acceptance of Marketing Authorization Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection

27 Jul 2015

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