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RSS FeedPosted by Michael Wonder on 18 May 2019
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 ...
Posted by Michael Wonder on 15 May 2019
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 ...
Posted by Michael Wonder on 12 May 2019
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 ...
Posted by Michael Wonder on 09 May 2019
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 ...
Posted by Michael Wonder on 08 May 2019
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, ...
Posted by Michael Wonder on 06 May 2019
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 ...
Posted by Michael Wonder on 03 May 2019
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 ...
Posted by Michael Wonder on 01 May 2019
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. ...
Posted by Michael Wonder on 30 Apr 2019
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 ...
Posted by Michael Wonder on 30 Apr 2019
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 ...
Posted by Michael Wonder on 29 Apr 2019
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 ...
Posted by Michael Wonder on 28 Apr 2019
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. ...
Posted by Michael Wonder on 27 Apr 2019
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 ...
Posted by Michael Wonder on 25 Apr 2019
Aytu BioScience announces submission of ZolpiMist for approval to Australian TGA
24 April 2019 - Australian TGA approval decision expected in early 2020. ...
Posted by Michael Wonder on 23 Apr 2019
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 ...