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RSS FeedPosted by Michael Wonder on 07 Sep 2017
NeuroRx awarded FDA fast track designation for first drug regimen targeting suicide in bipolar depression
6 September 2017 - NeuroRx has been granted fast track status by the US FDA for its sequential therapy of NRX-100 ...
Posted by Michael Wonder on 07 Sep 2017
Verastem expands duvelisib development program to include peripheral T-cell lymphoma
6 Septemner 2017 - Duvelisib receives fast track designation from FDA in peripheral T-cell lymphoma; company to initiate a phase 2 ...
Posted by Michael Wonder on 07 Sep 2017
Novimmune receives rare paediatric disease designation from the FDA for its lead drug emapalumab
5 September 2017 - Providing eligibility is confirmed at the time of approval of emapalumab for the treatment of primary haemophagocytic ...
Posted by Michael Wonder on 07 Sep 2017
Enzyvant receives FDA rare paediatric disease designation for investigational therapy RVT-802
5 September 2017 - RVT-802 has also received breakthrough therapy designation, regenerative medicine advanced therapy designation, and orphan drug designation from ...
Posted by Michael Wonder on 07 Sep 2017
Global Blood Therapeutics receives rare paediatric disease designation from FDA for GBT440 for treatment of sickle cell disease
5 September 2017 - Global Blood Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation to GBT440 ...
Posted by Michael Wonder on 06 Sep 2017
We may soon learn just how flexible Scott Gottlieb's FDA is
6 September 2017 - One the FDA's biggest controversies is coming back to test its new leadership. ...
Posted by Michael Wonder on 06 Sep 2017
AbbVie submits new drug application to U.S. FDA for investigational oral treatment elagolix for the management of endometriosis with associated pain
6 September 2017 - If approved by the FDA, elagolix will be the first new medical management treatment option for endometriosis-associated ...
Posted by Michael Wonder on 03 Sep 2017
SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
31 August 2017 - Company to meet and work with FDA to address issues raised. ...
Posted by Michael Wonder on 03 Sep 2017
FDA accepts Amgen's filing of a supplemental new drug application to add overall survival results to Kyprolis (carfilzomib) label
30 August 2017 - FDA sets PDUFA target action date of 30 April 2018 ...
Posted by Michael Wonder on 03 Sep 2017
Sanofi receives tentative FDA approval of Admelog (insulin lispro) 100 units/mL
1 September 2017 - Sanofi announced today that the U.S. FDA granted tentative approval for Admelog (insulin lispro injection) 100 ...
Posted by Michael Wonder on 02 Sep 2017
Apricus Biosciences announces FDA acknowledgement of Vitaros Class 2 NDA resubmission
31 August 2017 - Apricus Biosciences today announced that the U.S. FDA has acknowledged receipt of its recently resubmitted new drug ...
Posted by Michael Wonder on 01 Sep 2017
FDA approves Mylotarg for treatment of acute myeloid leukaemia
1 September 2017 - The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with ...
Posted by Michael Wonder on 31 Aug 2017
A cancer doctor weighs in on CAR-T, precision medicine and pricing debates
31 August 2017 - Yesterday’s historic FDA approval of the first engineered T-cell treatment for cancer, Novartis’ Kymriah (tisagenlecleucel), was accompanied ...
Posted by Michael Wonder on 31 Aug 2017
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
31 August 2017 - Clinical trials play a critically important role in bringing to market innovative new therapies for patients ...
Posted by Michael Wonder on 31 Aug 2017
FDA expands use of Teva’s Austedo in Parkinson’s
31 August 2017 - Teva’s Austedo is now the first and only therapy approved in the US to treat both ...