Latest News in the pharma Industry

Policy & Regulation

FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif for treatment of advanced SCC of the lung

FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif for treatment of advanced SCC of the lung

27 Aug 2015

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Rx-360 summary of WHO Annex 5 technical supplemets

Rx-360 summary of WHO Annex 5 technical supplemets

24 Aug 2015

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Mylan statement in response to FDA warning letter relating to certain Agila facilities

Mylan statement in response to FDA warning letter relating to certain Agila facilities

21 Aug 2015

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Rx-360 summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s

Rx-360 summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s

21 Aug 2015

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Novartis Drug Odomzo Gains EU Approval for Locally Advanced Basal Cell Carcinoma

Novartis Drug Odomzo Gains EU Approval for Locally Advanced Basal Cell Carcinoma

20 Aug 2015

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TGA Approves First mAb Biosimilar

TGA Approves First mAb Biosimilar

20 Aug 2015

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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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