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RSS FeedPosted 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 21 Dec 2019
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
20 December 2019 - Today, the U.S. FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with ...
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 20 Dec 2019
First FDA approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response
19 December 2019 - The U.S. FDA announced today the approval of Ervebo, the first FDA approved vaccine for the prevention ...
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
North America trade pact deals rare setback to big pharma
19 December 2019 - A revamped North American trade deal nearing passage in Congress gives both the White House and ...
Posted by Michael Wonder on 19 Dec 2019
Lilly launches campaign to increase awareness of insulin cost saving options
19 December 2019 - Letter from CEO urges people to call the Lilly Diabetes Solution Center. ...
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
Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA
18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...
Posted by Michael Wonder on 18 Dec 2019
Orphazyme’s arimoclomol receives US fast track designation in sporadic inclusion body myositis
18 December 2019 - Orphazyme today received fast track designation from the US FDA for the development of arimoclomol for the ...