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RSS FeedPosted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020. ...
Posted by Michael Wonder on 12 Feb 2020
FibroGen announces U.S. FDA acceptance of new drug application for roxadustat for the treatment of anaemia of chronic kidney disease
11 February 2020 - FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing ...
Posted by Michael Wonder on 12 Feb 2020
Astex Pharmaceuticals announces U.S. FDA acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML
11 February 2020 - FDA designated the application for priority review. ...
Posted by Michael Wonder on 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children. ...
Posted by Michael Wonder on 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
11 February 2020 - Capmatinib review expected to be completed within six months. ...
Posted by Michael Wonder on 11 Feb 2020
Trevena resubmits new drug application for oliceridine
10 February 2020 - Oliceridine is a new chemical entity intended for the management of moderate-to-severe acute pain. ...
Posted by Michael Wonder on 11 Feb 2020
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for Libervant (diazepam) buccal film
10 February 2020 - Assigned Prescription Drug User Fee Act goal date of 27 September 2020. ...
Posted by Michael Wonder on 11 Feb 2020
Janssen announces submission to U.S. FDA for new Darzalex (daratumumab)-based combination regimen for patients with relapsed/refractory multiple myeloma
10 February 2020 - Application is based on positive data from the Phase 3 CANDOR study, which were presented at the ...
Posted by Michael Wonder on 11 Feb 2020
U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma
10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies. ...
Posted by Michael Wonder on 07 Feb 2020
Revance announces U.S. FDA acceptance of biologics license application for DAXI to treat glabellar (frown) lines
6 February 2020 - Prescription Drug User Fee Act target action date of 25 November 2020. ...
Posted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...
Posted by Michael Wonder on 05 Feb 2020
Mesoblast submits completed biologics license application for Ryoncil to US FDA
3 February 2020 - Mesoblast today announced that it has submitted its completed niologics license application to the US FDA ...
Posted by Michael Wonder on 04 Feb 2020
GW Pharmaceuticals and Greenwich Biosciences submit supplemental new drug application to U.S. FDA for Epidiolex (cannabidiol) for the treatment of tuberous sclerosis complex
3 February 2020 - GW Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 04 Feb 2020
TherapeuticsMD announces submission of new drug application prior approval efficacy supplement to the U.S. FDA for lower dose of Bijuva
3 February 2020 - TherapeuticsMD announced today that it submitted a new drug application prior-approval efficacy supplement for Bijuva 0.5 ...
Posted by Michael Wonder on 02 Feb 2020
Bayer application for nifurtimox to treat paediatric patients with Chagas disease submitted for approval in US
30 January 2020 - Submission based on results of CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study ...