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RSS FeedPosted by Michael Wonder on 12 Aug 2019
Avadel Pharmaceuticals receives new PDUFA date for AV001 of 15 December 2019
8 August 2019 - PDUFA action extended 3 months; launch remains on track for 1Q 2020. ...
Posted by Michael Wonder on 08 Aug 2019
DBV Technologies submits biologics license application to U.S. FDA for Viaskin Peanut for the treatment of peanut allergy
7 August 2019 - DBV Technologies today announced the submission of its biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 07 Aug 2019
Ortho Dermatologics announces U.S. FDA filing acceptance for IDP-123 treatment for acne vulgaris in lotion form
7 August 2019 - Bausch Health and its dermatology business, Ortho Dermatologics, today announced that the U.S. FDA has accepted the ...
Posted by Michael Wonder on 07 Aug 2019
Blueprint Medicines announces FDA acceptance of new drug application for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
7 August 2019 - FDA grants priority review and sets PDUFA date for 14 February 2020. ...
Posted by Michael Wonder on 06 Aug 2019
Rockwell Medical announces acceptance by FDA of new drug application for I.V. Triferic
6 August 2019 - FDA establishes PDUFA date of 28 March 2020 for I.V. Triferic ...
Posted by Michael Wonder on 05 Aug 2019
Foamix submits new drug application to U.S. FDA for FMX103 for the treatment of moderate-to-severe papulopustular rosacea
5 August 2019 - Foamix Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 05 Aug 2019
Alnylam announces U.S. FDA granted priority review of the givosiran new drug application for the treatment of acute hepatic porphyria
5 August 2019 - PDUFA date set for 4 February 2020. ...
Posted by Michael Wonder on 05 Aug 2019
AbbVie submits new drug application to US FDA for investigational elagolix for management of heavy menstrual bleeding associated with uterine fibroids in women
5 August 2019 - New drug application is supported by data from pivotal Phase 3 studies of nearly 800 patients. ...
Posted by Michael Wonder on 01 Aug 2019
Eton Pharmaceuticals announces FDA acceptance of new drug application for ET-105
1 August 2019 - ET-105 assigned Prescription Drug User Fee Act target action date of 17 March 2020. ...
Posted by Michael Wonder on 01 Aug 2019
Ultragenyx announces submission of new drug application to FDA for UX007 (triheptanoin) for treatment of long-chain fatty acid oxidation disorders
1 August 2019 - Ultragenyx today announced that it has submitted to the U.S. FDA a new drug application for UX007 ...
Posted by Michael Wonder on 31 Jul 2019
Sunovion announces acceptance by the U.S. FDA of the new drug application for dasotraline for the treatment of adults with moderate-to-severe binge eating disorder
30 July 2019 - Binge eating disorder is estimated to affect 4.1 million Americans and may occur at a rate that ...
Posted by Michael Wonder on 25 Jul 2019
Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat for the treatment of epithelioid sarcoma
25 July 2019 - Company aligns with FDA on planned confirmatory study design for tazemetostat in epithelioid sarcoma. ...
Posted by Michael Wonder on 25 Jul 2019
U.S. FDA accepts Correvio's resubmitted new drug application for Brinavess (vernakalant)
25 July 2019 - NDA seeks pproval for Brinavess for the treatment of recent onset atrial fibrillation; PDUFA date set for ...
Posted by Michael Wonder on 22 Jul 2019
Vertex submits new drug application to the U.S. FDA for triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor in cystic fibrosis
22 July 2019 - Application supported by positive results from two global Phase 3 studies in people with CF ages 12 ...
Posted by Michael Wonder on 20 Jul 2019
Pear Therapeutics announces FDA submission for Somryst, a prescription digital therapeutic for the treatment of adults with chronic insomnia and depression
18 July 2019 - The pending submission is supported by data from two randomised controlled clinical trials of more than 1,400 ...