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RSS FeedPosted by Michael Wonder on 10 Jan 2020
Alnylam initiates rolling submission of new drug application to U.S. FDA for lumasiran for the treatment of primary hyperoxaluria type 1
10 January 2020 - Company plans to complete submission in early 2020. ...
Posted by Michael Wonder on 10 Jan 2020
Eagle Pharmaceuticals resubmits NDA for Ryanodex for exertional heat stroke
9 January 2020 - Eagle Pharmaceuticals today announced that the Company has resubmitted its new drug application for Ryanodex (dantrolene sodium ...
Posted by Michael Wonder on 10 Jan 2020
Blueprint Medicines initiates rolling NDA submission to FDA for pralsetinib for the treatment of patients with RET fusion positive non-small cell lung cancer
8 January 2020 - Expect to complete NDA rolling submission for RET fusion-positive non-small cell lung cancer in Q1 2020. ...
Posted by Michael Wonder on 09 Jan 2020
Nabriva Therapeutics receives FDA acknowledgement of new drug application resubmission for intravenous Contepo (fosfomycin) for injection
8 January 2020 - PDUFA action date set for 19 June 2020. ...
Posted by Michael Wonder on 07 Jan 2020
RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection new drug application
7 January 2020 - RadioMedix and its commercial partner Curium announced today that the new drug application for copper Cu 64 ...
Posted by Michael Wonder on 06 Jan 2020
Farxiga granted FDA priority review for patients with heart failure with reduced ejection fraction
6 January 2020 - AstraZeneca today announced the US FDA has accepted a supplemental new drug application and granted Priority ...
Posted by Michael Wonder on 31 Dec 2019
Urovant Sciences announces submission of new drug application for vibegron for the treatment of overactive bladder
30 December 2019 - Urovant Sciences announced today that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 31 Dec 2019
MorphoSys announces submission of biologics license application for tafasitamab in r/r DLBCL to the FDA
30 December 2019 - MorphoSys announced today that it has submitted a biologics license application to the U.S. FDA for tafasitamab, ...
Posted by Michael Wonder on 28 Dec 2019
Luye Pharma submits new drug application in the U.S. for its anti-depressant drug LY03005
26 December 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 24 Dec 2019
FibroGen submits new drug application to the U.S. FDA for roxadustat in patients with anaemia of chronic kidney disease
23 December 2019 - New drug application supported by positive global Phase 3 efficacy and safety results. ...
Posted by Michael Wonder on 24 Dec 2019
Zosano announces FDA submission of new drug application for Qtrypta
23 December 2019 - Zosano Pharma today announced the submission of a 505(b)(2) new drug application for Qtrypta to the U.S. ...
Posted by Michael Wonder on 24 Dec 2019
BioMarin submits biologics license application to U.S. FDA for valoctocogene roxaparvovec to treat haemophilia A
23 December 2019 - First marketing application submission in U.S. for gene therapy directed at any type of haemophilia. ...
Posted by Michael Wonder on 24 Dec 2019
Seattle Genetics announces submission of tucatinib new drug application to the U.S. FDA for patients with locally advanced or metastatic HER2 positive breast cancer
23 December 2019 - Submission based on positive pivotal HER2CLIMB trial results recently oresented at the 2019 San Antonio Breast Cancer ...
Posted by Michael Wonder on 24 Dec 2019
Karyopharm submits new drug application to U.S. FDA for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma
23 December 2019 - Karyopharm Therapeutics today announced it has submitted a new drug application to the U.S. FDA seeking accelerated ...
Posted by Michael Wonder on 21 Dec 2019
Sunovion announces FDA filing acceptance of resubmitted new drug application for apomorphine sublingual film
20 December 2019 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted its new drug application for apomorphine ...