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RSS FeedPosted by Michael Wonder on 10 Mar 2017
Keryx Biopharmaceuticals announces U.S. FDA filing acceptance of supplemental new drug application for Auryxia (ferric citrate) tablets
8 March 2017 - Keryx Biopharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 10 Mar 2017
Nicox resubmits AC-170 (Zerviate) NDA to the U.S. FDA
9 March 2017 - CGMP issues at the API manufacturer have been resolved. ...
Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase ...
Posted by Michael Wonder on 09 Mar 2017
PTC Therapeutics announces FDA acknowledgment of new drug application filing for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
6 March 2017 - FDA has assigned a PDUFA date of 24 October 2017. ...
Posted by Michael Wonder on 08 Mar 2017
FDA accepts supplemental new drug application for Vraylar (cariprazine)
8 March 2017 - Application seeks to expand Vraylar label to include phase 3 clinical data for the maintenance treatment ...
Posted by Michael Wonder on 07 Mar 2017
FDA grants fast track designation for Mesoblast's cell therapy in children with acute graft versus host disease
7 March 2017 - Mesoblast today announced that the US FDA has granted a fast track designation for the use of ...
Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin. ...
Posted by Michael Wonder on 05 Mar 2017
Acerus files a new drug submission for Gynoflor in Canada
1 March 2017 - Acerus Pharmaceuticals today announced that it has filed a new drug submission for Gynoflor with Health Canada. ...
Posted by Michael Wonder on 02 Mar 2017
FDA accepts new drug application and grants priority review for enasidenib in relapsed or refractory AML with an IDH2 mutation
1 March 2017 - PDUFA date set for 30 August 2017. ...
Posted by Michael Wonder on 02 Mar 2017
Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for Heplisav-B
28 February 2017 - Dynavax Technologies announced today that the U.S. FDA has accepted for review Dynavax's responses to the complete ...
Posted by Michael Wonder on 01 Mar 2017
Teva announces priority review granted by FDA for SD-809 for treatment of tardive dyskinesia
28 February 2017 - Teva Pharmaceutical Industries today announced the U.S. FDA has accepted the new drug application and granted ...
Posted by Michael Wonder on 28 Feb 2017
OncoSec granted FDA fast track designation for ImmunoPulse IL-12 for the treatment of metastatic melanoma following progression on pembrolizumab or nivolumab
28 February 2017 - Provides opportunities for upcoming Phase 2b PISCES clinical trial and future clinical development. ...
Posted by Michael Wonder on 25 Feb 2017
Auris Medical receives FDA fast track designation for AM-111 in acute sensorineural hearing loss
24 February 2017 - Auris Medical today announced that the US FDA has granted fast track designation for AM-111 in ...
Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ...
Posted by Michael Wonder on 22 Feb 2017
Lead cancer immunotherapy candidate receives FDA fast track designation
21 February 2017 - Cell Medica today announced the U.S. FDA has granted fast rrack designation to its lead oncology ...