Latest News in the pharma Industry

Policy & Regulation

Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures

Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures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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Novartis receives EU Approval for Jakavi in Polycythemia Vera, First Targeted Therapy Approved for Patients with this Rare Blood Cancer?

Novartis receives EU Approval for Jakavi in Polycythemia Vera, First Targeted Therapy Approved for Patients with this Rare Blood Cancer?

17 Mar 2015

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Actavis Confirms Appeals Court Grants Injunction Pending Appeal Related to Generic Pulmicort Respules

Actavis Confirms Appeals Court Grants Injunction Pending Appeal Related to Generic Pulmicort Respules

13 Mar 2015

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FDA Approves First Therapy for High-Risk Neuroblastoma

FDA Approves First Therapy for High-Risk Neuroblastoma

11 Mar 2015

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Astellas Receives FDA Approval for Cresemba

Astellas Receives FDA Approval for Cresemba

9 Mar 2015

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