Blog
RSS FeedPosted by Michael Wonder on 07 Sep 2016
Sage receives FDA breakthrough therapy designation for SAGE-547 for the treatment of postpartum depression
6 September 2016 - Designation offers potential for expedited development and review, and underscores significant unmet need in women with postpartum ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 07 Sep 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
6 September 2016 - This study, published in JAMA, uses US FDA data to identify approved generic drugs manufactured between September ...
Posted by Michael Wonder on 03 Sep 2016
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
2 September 2016 - The U.S. FDA today allowed marketing of two Trevo clot retrieval devices as an initial therapy for ...
Posted 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 ...