Latest News in the pharma Industry

Policy & Regulation

FDA Performs GMP and Pre-Approval Inspections of Impax's Hayward Facility

FDA Performs GMP and Pre-Approval Inspections of Impax's Hayward Facility

12 May 2015

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Novartis Lung Cancer Drug Zykadia Gains EU Approval, Providing New Therapy for Certain Patients with ALK+ NSCLC

Novartis Lung Cancer Drug Zykadia Gains EU Approval, Providing New Therapy for Certain Patients with ALK+ NSCLC

8 May 2015

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Novartis Lung cancer Drug Zykadia Gains EU Approval, Providing New Therapy for Certain Patients with ALK+ NSCLC

Novartis Lung cancer Drug Zykadia Gains EU Approval, Providing New Therapy for Certain Patients with ALK+ NSCLC

7 May 2015

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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Healthcare Antiseptics?

FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Healthcare Antiseptics?

1 May 2015

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FDA Issues Draft Guidance for Industry on Electronic and Non-Electronic Submissions of Promotional Materials for Human Prescription Drugs and Biologic Products?

FDA Issues Draft Guidance for Industry on Electronic and Non-Electronic Submissions of Promotional Materials for Human Prescription Drugs and Biologic Products?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Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures

Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures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