Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Dec 2019
Nabriva Therapeutics resubmits new drug application for intravenous Contepo (fosfomycin) for Injection
20 December 2019 - Nabriva anticipates a six month review period by the Food and Drug Administration. ...
Posted by Michael Wonder on 21 Dec 2019
Evoke resubmits Gimoti new drug application to FDA
20 December 2019 - Evoke Pharma today announced that it has resubmitted its 505(b)(2) new drug application to the U.S. ...
Posted by Michael Wonder on 21 Dec 2019
Gilead submits filgotinib new drug application to U.S. FDA under priority review for rheumatoid arthritis treatment
19 December 2019 - Gilead Sciences announced today that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 20 Dec 2019
Amgen and Allergan submit biologics license application for ABP 798, biosimilar candidate to Rituxan (rituximab), to U.S. FDA
19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies. ...
Posted by Michael Wonder on 20 Dec 2019
MacroGenics announces submission of margetuximab biologics license application to U.S. FDA
19 December 2019 - MacroGenics today announced that the Company has submitted a biologics license application for margetuximab, an investigational, Fc-engineered, ...
Posted by Michael Wonder on 19 Dec 2019
UroGen Pharma announces FDA fling acceptance and priority review of U.S. new drug application for UGN-101
19 December 2019 - Potential for UGN 101 to be first non-surgical therapy for the treatment of low-grade upper tract urothelial ...
Posted by Michael Wonder on 19 Dec 2019
Averitas Pharma announces FDA acceptance of sNDA filing for Qutenza (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy
18 December 2019 - PDUFA date set for 19 July 2020. ...
Posted by Michael Wonder on 19 Dec 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with follicular lymphoma
18 December 2019 - Submission marks on-time execution of second submission for tazemetostat in 2019. ...
Posted by Michael Wonder on 18 Dec 2019
Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA
18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...
Posted by Michael Wonder on 18 Dec 2019
U.S. FDA acknowledges receipt of Evofem Biosciences' new drug application resubmission for Amphora for the prevention of pregnancy
18 December 2019 - Assigns PDUFA goal date of 25 May 2020. ...
Posted by Michael Wonder on 18 Dec 2019
U.S. FDA accepts and grants priority review to sNDA for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) for the treatment of BRAF V600E-mutant metastatic colorectal cancer after prior therapy
18 December 2019 - Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental ...
Posted by Michael Wonder on 18 Dec 2019
PharmaMar has filed new drug application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer
17 December 2019 - The application is based on the phase II multicenter basket trial data. ...