Latest News in the pharma Industry

Policy & Regulation

Lilly's Cyramza (Ramucirumab) Receives Fourth FDA Approval

Lilly's Cyramza (Ramucirumab) Receives Fourth FDA Approval

27 Apr 2015

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BMS Receives Positive CHMP Opinion in the EU for Nivolumab

BMS Receives Positive CHMP Opinion in the EU for Nivolumab

27 Apr 2015

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FDA Issues Draft Guidance for Industry on Electronic and Non-Electronic Submissions of Promotional Materials for Human Prescription Drugs and Biologic Products?

FDA Issues Draft Guidance for Industry on Electronic and Non-Electronic Submissions of Promotional Materials for Human Prescription Drugs and Biologic Products?

22 Apr 2015

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Sandoz Receives FDA Approval for Glatopa as the First Generic Competitor to MS Therapy Copaxone 20 mg

Sandoz Receives FDA Approval for Glatopa as the First Generic Competitor to MS Therapy Copaxone 20 mg

17 Apr 2015

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Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures

Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures

10 Apr 2015

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Novo Nordisk to Resubmit the New Drug Applications of Tresiba and Ryzodeg in the US

Novo Nordisk to Resubmit the New Drug Applications of Tresiba and Ryzodeg in the US

9 Apr 2015

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FDA Issues Guidance on Risk Evaluation and Mitigation Strategies: Modifications and Revisions

FDA Issues Guidance on Risk Evaluation and Mitigation Strategies: Modifications and Revisions

7 Apr 2015

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FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa

FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa

6 Apr 2015

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Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA

Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA

1 Apr 2015

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EMA Validates Marketing Authorisation Application for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS

EMA Validates Marketing Authorisation Application for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS

30 Mar 2015

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Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

30 Mar 2015

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BIO Urges Governor Herbert to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines

BIO Urges Governor Herbert to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines

18 Mar 2015

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