Agile Therapeutics resubmits new drug application for its transdermal low-dose contraceptive patch, Twirla

17 May 2019 - Agile Therapeutics today announced it has resubmitted to the U.S. FDA the new drug application for its ...

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Lipocine announces Tlando NDA PDUFA action date of 9 November 2019

14 May 2019 - Lipocine today announced that the U.S.FDA has accepted its new drug application for Tlando as testosterone ...

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U.S. FDA accepts Takeda’s biologics license application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis

9 May 2019 - An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a ...

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Nabriva Therapeutics announces submission of marketing authorisation application for lefamulin to treat community-acquired pneumonia in adults by European Medicines Agency

8 May 2019 - Nabriva Therapeutics announced that the Company’s marketing authorisation application for both the intravenous  and oral ...

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RedHill Biopharma submits new drug application for Talicia for H. pylori Infection

7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, ...

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Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review

5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...

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Acacia Pharma receives complete response letter from FDA for Barhemsys

3 May 2019 - Acacia Pharma announces that it has received a second complete response letter from the US FDA ...

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Janssen submits application to U.S. FDA seeking approval of Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer

29 April 2019 - Supplemental new drug application supported by Phase 3 TITAN study; submitted through FDA real-time oncology review program. ...

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New drug submission filed for Vascepa with Health Canada

29 April 2019 - Amarin Corporation today announced that its licensee in Canada, HLS Therapeutics has filed a new drug ...

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Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV

29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living ...

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U.S. FDA accepts new drug application and grants priority review for darolutamide

29 April 2019 - Bayer today announced the U.S. FDA has accepted the new drug application and granted priority review to ...

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Celgene Corporation and Acceleron Pharma announce submission of luspatercept marketing authorisation application to the EMA for MDS and beta-thalassemia

26 April 2019 - Submission to EMA follows biologics licensing application submission to U.S. FDA earlier this month. ...

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Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of type 2 diabetes

26 April 2019 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for oral ...

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Aytu BioScience announces submission of ZolpiMist for approval to Australian TGA

24 April 2019 - Australian TGA approval decision expected in early 2020. ...

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Priority review vouchers have helped to improve access to drugs targeting neglected diseases

22 April 2019 - The FDA priority review vouchers for neglected tropical diseases are aimed to incentivise pharmaceutical companies to ...

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