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RSS FeedPosted 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 ...
Posted by Michael Wonder on 30 Jan 2020
Corium announces FDA filing acceptance of new drug application for Adlarity (donepezil transdermal system) for the treatment of Alzheimer’s disease
27 January 2020 - Corium today announced that the U.S. FDA has accepted for filing the company’s new drug application ...
Posted by Michael Wonder on 29 Jan 2020
Lilly receives FDA priority review for the selpercatinib new drug application
29 January 2020 - Eli Lilly announced today that the U.S. FDA has granted priority review for the new drug application ...
Posted by Michael Wonder on 28 Jan 2020
Alkermes announces U.S. FDA acceptance of ALKS 3831 new drug application for treatment of schizophrenia and bipolar I disorder
28 January 2020 - Alkermes today announced that the U.S. FDA has accepted for review the company's new drug application ...