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RSS FeedPosted by Michael Wonder on 29 Aug 2017
La Jolla Pharmaceutical Company announces U.S. FDA acceptance of new drug application for LJPC-501
28 August 2017 - Priority review granted. ...
Posted by Michael Wonder on 25 Aug 2017
Ultragenyx and Kyowa Hakko Kirin announce submission of burosumab's biologics license application in the US
24 August 2017 - Ultragenyx and Kyowa Hakko Kirin today announced that Ultragenyx has submitted a biologics license application with ...
Posted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 24 Aug 2017
Cardiome provides U.S. regulatory update for Brinavess
21 August 2017 - Cardiome Pharma Corporation today announced that it has received a response from the U.S. FDA regarding the ...
Posted by Michael Wonder on 22 Aug 2017
Alkermes initiates rolling submission of ALKS 5461 new drug application for major depressive disorder
21 August 2017 - Company expects to complete submission for fast track designated medicine by year-end 2017. ...
Posted by Michael Wonder on 17 Aug 2017
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for the treatment of previously untreated advanced kidney cancer
16 August 2017 - Cabometyx is the first therapy to demonstrate a clinically meaningful and statistically significant progression-free survival benefit over ...
Posted by Michael Wonder on 17 Aug 2017
Portola Pharmaceuticals announces AndexXa (andexanet alfa) biologics license application resubmission accepted for review by U.S. FDA
15 August 2017 - Portola Pharmaceuticals today announced that the U.S. FDA has found its resubmitted biologics license application for ...
Posted by Michael Wonder on 16 Aug 2017
Lipocine announces FDA acknowledgement of Tlando ("LPCN 1021") NDA resubmission; PDUFA goal date, 8 February 2018
14 August 2017 - Lipocine today announced that the U.S FDA has acknowledged receipt of the company's new drug application ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces US FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 10 Aug 2017
FDA issues a complete response letter on CCP-08 NDA
7 August 2017 - Vernalis announced today that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 04 Aug 2017
Dynavax provides U.S. regulatory update on Heplisav following FDA Advisory Committee meeting
3 August 2017 - Dynavax Technologies Corporation today announced that the U.S. FDA has requested more detailed information about the company's ...
Posted by Michael Wonder on 04 Aug 2017
Portola Pharmaceuticals announces resubmission of biologics license application for AndexXa (andexanet alfa)
3 August 2017 - Portola Pharmaceuticals today announced that on August 3, 2017 it resubmitted its Biologics License Application (BLA) ...
Posted by Michael Wonder on 04 Aug 2017
FDA grants Genentech’s Alecensa priority review for initial treatment of people with ALK positive lung cancer
4 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 03 Aug 2017
US FDA accepts regulatory submission for acalabrutinib and grants priority review
2 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the ...
Posted by Michael Wonder on 31 Jul 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Herceptin (trastuzumab)
31 July 2017 - Celltrion and Teva Pharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license ...