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RSS FeedPosted by Michael Wonder on 02 Dec 2019
Innovent Biologics announces FDA acceptance of NDA for pemigatinib in patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
1 December 2019 - Innovent Biologics today announced that the new drug application submitted by Incyte to the U.S. FDA for ...
Posted by Michael Wonder on 30 Nov 2019
Y-mAbs initiates rolling submission of biologics license application to U.S. FDA for naxitamab for treatment of neuroblastoma
29 November 2019 - Y-mAbs Therapeutics today announced that it has submitted to the U.S. FDA the first portions of ...
Posted by Michael Wonder on 28 Nov 2019
Verrica Pharmaceuticals announces FDA filing acceptance of new drug application for VP-102 for the treatment of molluscum contagiosum
27 November 2019 - PDUFA date assigned is 13 July 2020. ...
Posted by Michael Wonder on 28 Nov 2019
Incyte announces acceptance and priority review of NDA for pemigatinib as a treatment for patients with cholangiocarcinoma
27 November 2019 - Incyte today announced that the U.S. FDA has accepted for Priority Review its new drug application for ...
Posted by Michael Wonder on 27 Nov 2019
Evofem Biosciences resubmits new drug application to U.S. FDA for Amphora for the prevention of pregnancy
26 November 2019 - FDA decision anticipated within six months. ...
Posted by Michael Wonder on 27 Nov 2019
Revance submits biologics license application to the FDA for DAXI to treat glabellar (frown) lines
25 November 2019 - Revance Therapeutics today announced the Company has submitted a biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 25 Nov 2019
FDA accepts Intercept’s new drug application for OCA for the treatment of liver fibrosis due to NASH and grants priority review
25 November 2019 - NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of ...
Posted by Michael Wonder on 25 Nov 2019
Zogenix announces FDA acceptance for filing of new drug application and priority review for Fintelpa for the treatment of Dravet syndrome
25 November 2019 - NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met ...
Posted by Michael Wonder on 25 Nov 2019
FDA grants priority review to Roche’s risdiplam for spinal muscular atrophy
25 November 2019 - Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people ...
Posted by Michael Wonder on 24 Nov 2019
Sunovion resubmits new drug application for apomorphine sublingual film
22 November 2019 - Sunovion Pharmaceuticals today announced the resubmission of the new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 21 Nov 2019
MC2 Therapeutics announces FDA acceptance of its new drug application for Wynzora cream for treatment of plaque psoriasis
20 November 2019 - MC2 Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 20 Nov 2019
Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder
19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 17 Nov 2019
Tricida announces FDA acceptance of new drug application for veverimer
14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 14 Nov 2019
US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review
14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...