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RSS FeedPosted by Michael Wonder on 31 May 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with epithelioid sarcoma
30 May 2019 - Submission follows productive pre-NDA meeting and marks on-time execution of first of two NDA submissions planned for ...
Posted by Michael Wonder on 30 May 2019
Rockwell Medical announces submission of new drug application for I.V. Triferic
29 May 2019 - I.V. Triferic was developed through Special Protocol Assessment with FDA based on equivalence approach to Dialysate Triferic. ...
Posted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...
Posted by Michael Wonder on 23 May 2019
Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001
22 May 2019 - AV001 granted priority review. ...
Posted by Michael Wonder on 22 May 2019
Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla
22 May 2019 - FDA assigns Prescription Drug User Fee Act goal date of 16 November 2019. ...
Posted by Michael Wonder on 22 May 2019
U.S. FDA grants priority review of Invokana (canagliflozin) sNDA for the treatment of chronic kidney disease in patients with type 2 diabetes
22 May 2019 - Application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in ...
Posted 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 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
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 ...