Latest News in the pharma Industry

Policy & Regulation

FDA Accepts Filing of NDA for Empagliflozin/Metformin Fixed-Dose Combination

FDA Accepts Filing of NDA for Empagliflozin/Metformin Fixed-Dose Combination

22 Oct 2014

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FDA Advisory Committee Unanimously Recommends Approval of Novartis' AIN457 for Patients with Moderate-to-Severe Plaque Psoriasis

FDA Advisory Committee Unanimously Recommends Approval of Novartis' AIN457 for Patients with Moderate-to-Severe Plaque Psoriasis

21 Oct 2014

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FDA Approves Boehringer Ingelheim's Ofev as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis

FDA Approves Boehringer Ingelheim's Ofev as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis

16 Oct 2014

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FDA Approves Gilead’s Harvoni, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

FDA Approves Gilead’s Harvoni, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

14 Oct 2014

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Valeant Pharmaceuticals' Bridgewater Location Receives Warning Letter from FDA

Valeant Pharmaceuticals' Bridgewater Location Receives Warning Letter from FDA

2 Oct 2014

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Facilitating Applications for Paediatric Investigation Plans

Facilitating Applications for Paediatric Investigation Plans

1 Oct 2014

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EMA Validates the Marketing Authorization Application for Nivolumab in Non-Small Cell Lung Cancer

EMA Validates the Marketing Authorization Application for Nivolumab in Non-Small Cell Lung Cancer

30 Sep 2014

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Summary of the Revised EU GMP Chapters 3, 5 and 8

Summary of the Revised EU GMP Chapters 3, 5 and 8

26 Sep 2014

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Shire Reaches Final Agreement with US Government

Shire Reaches Final Agreement with US Government

25 Sep 2014

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Regeneron Announces Eylea Injection Approved for the Treatment of Patients with Myopic CNV in Japan

Regeneron Announces Eylea Injection Approved for the Treatment of Patients with Myopic CNV in Japan

22 Sep 2014

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ProductLife Group Kicks off Autumn Event Programme With Regulatory Information Management Webinar on IDMP

ProductLife Group Kicks off Autumn Event Programme With Regulatory Information Management Webinar on IDMP

15 Sep 2014

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Takeda and Orexigen Announce FDA Approval of Contrave Extended-Release Tablets for Chronic Weight Management

Takeda and Orexigen Announce FDA Approval of Contrave Extended-Release Tablets for Chronic Weight Management

12 Sep 2014

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