Blog
RSS FeedPosted by Michael Wonder on 03 Sep 2016
FDA approves Blincyto (blinatumomab) for use In paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 September 2016 - Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) ...
Posted by Michael Wonder on 01 Sep 2016
Biogen’s investigational Alzheimer’s disease treatment aducanumab granted FDA fast track designation
1 September 2016 - Company also provides update on new interim analysis from phase 1b study. ...
Posted by Michael Wonder on 01 Sep 2016
FDA accepts Mitsubishi Tanabe Pharma’s NDA filing for edaravone to treat ALS
30 August 2016 - Edaravone may be the first ALS treatment approved in U.S. in more than 20 years. ...
Posted by Michael Wonder on 01 Sep 2016
ARIAD completes rolling submission of new drug application for brigatinib to the U.S. FDA
30 August 2016 - ARIAD Pharmaceuticals today announced it has completed the rolling submission of the new drug application for its ...
Posted by Michael Wonder on 01 Sep 2016
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL
31 August 2016 - Arzerra now approved by U.S. FDA for use in combination with fludarabine and cyclophosphamide in relapsed CLL ...
Posted by Michael Wonder on 31 Aug 2016
Neurocrine submits new drug application for valbenazine for treatment of tardive dyskinesia
29 August 2016 - Neurocrine Biosciences today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 30 Aug 2016
FDA approves Sandoz Erelzi to treat multiple inflammatory diseases
30 August 2016 - Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine. ...
Posted by Michael Wonder on 30 Aug 2016
FDA accepts CSL Behring’s BLA for first subcutaneous prophylactic therapy to prevent hereditary angioedema attacks
30 August 2016 - CSL today announced that the US FDA has accepted for review CSL Behring’s biologics license application for ...
Posted by Michael Wonder on 30 Aug 2016
Seqirus receives FDA approval for Afluria Quadrivalent (influenza vaccine) for people 18 years of age and older
29 August 2016 - Seqirus is shipping trivalent and quadrivalent formulations of Afluria in the 2016-2017 influenza season. ...
Posted by Michael Wonder on 29 Aug 2016
Cynapsus Therapeutics receives FDA fast track designation for APL-130277 for the treatment of off episodes in patients with Parkinson’s disease
29 August 2016 - Cynapsus Therapeutics today announced that the U.S. FDA has granted fast track designation for APL-130277, a product ...
Posted by Michael Wonder on 28 Aug 2016
Amgen's shameful silence covers up reasons for FDA drug rejection
25 August 2016 - An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. FDA but the company has offered ...
Posted by Michael Wonder on 25 Aug 2016
Mallinckrodt receives FDA fast track designation for Synacthen Depot IND application
25 August 2016 - Expedites potential treatment for Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 25 Aug 2016
PhRMA and BIO give support for PDUFA VI performance goals
24 August 2016 - Both PhRMA and BIO have said they are pleased with the performance goals outlined by and ...
Posted by Michael Wonder on 24 Aug 2016
Amgen provides update on status of Parsabiv (etelcalcetide) new drug application submitted to the U.S. FDA
24 August 2016 - Amgen today announced that the U.S. FDA has issued a complete response letter for the new drug ...
Posted by Michael Wonder on 23 Aug 2016
Stemline Therapeutics receives breakthrough therapy designation from U.S. FDA for SL-401
23 August 2016 - Stemline Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to SL-401. ...