Blog
RSS FeedPosted by Michael Wonder on 09 Jan 2019
The future of FDA's electronic safety surveillance
9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions. ...
Posted by Michael Wonder on 09 Jan 2019
Biotech proposes paying for pricey drugs by instalment
8 January 2019 - Bluebird Bio develops plan to sell gene-replacement therapy with annual payments contingent on continued effectiveness. ...
Posted by Michael Wonder on 08 Jan 2019
CDER’s work to ensure drug safety is an ongoing top priority
8 January 2019 - Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s wide array of new ...
Posted by Michael Wonder on 08 Jan 2019
All seven of the FDA’s recent commissioners agree it should be independent — but not on how to accomplish it
7 January 2019 - Nearly every person who’s run the FDA in recent history agrees the agency should break free ...
Posted by Michael Wonder on 08 Jan 2019
FDA plans to create a new office to leverage cutting-edge science
7 January 2019 - The FDA plans to create a new office to improve the review of new medicines — ...
Posted by Michael Wonder on 08 Jan 2019
Novartis investigational therapy crizanlizumab (SEG101) receives FDA breakthrough therapy designation for the prevention of vaso-occlusive crises in sickle cell disease
8 January 2019 - FDA filing of crizanlizumab anticipated in first half of 2019. ...
Posted by Michael Wonder on 07 Jan 2019
FDA grants Revalesio fast track status for ALS investigational drug RNS60
4 January 2019 - Revalesio announced today that the U.S. FDA granted fast track status for its investigational drug RNS60 as ...
Posted by Michael Wonder on 07 Jan 2019
Rainier Therapeutics announces fast track designation granted by FDA for vofatamab in treatment of FGFR3-positive urothelial cell carcinoma
7 January 2019 - Rainier Therapeutics today announced that its targeted antibody vofatamab has received fast track designation from the U.S. ...
Posted by Michael Wonder on 07 Jan 2019
2018: a year of innovation, efficiency, and new advances in drug therapy for the American public
7 January 2019 - The beginning of a new year is a good opportunity to look back over the past ...
Posted by Michael Wonder on 07 Jan 2019
ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter
7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...
Posted by Michael Wonder on 07 Jan 2019
KemPharm announces FDA approval of sNDA for two additional strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
7 January 2019 - Apadaz now approved in three dosage strengths, providing greater flexibility to prescribers through additional dosing options. ...
Posted by Michael Wonder on 06 Jan 2019
Slayback Pharma announces FDA approval of hydroxyprogesterone caproate injection, USP 1,250 mg/5 mL in a multi-dose vial, the first generic equivalent of Makena injection 1,250 mg/5 mL multi-dose vial
2 January 2019 - Slayback Pharma announced today that the U.S. FDA granted approval of its abbreviated new drug application ...
Posted by Michael Wonder on 06 Jan 2019
Banner receives FDA tentative approval for Bafiertam for the treatment of relapsing forms of multiple sclerosis
2 January 2019 - Banner Life Sciences announced today that the U.S. FDA granted tentative approval on 16 November 2018 ...
Posted by Michael Wonder on 06 Jan 2019
Nabriva Therapeutics announces acceptance of the new drug application for intravenous Contepo to treat complicated urinary tract infections by FDA
4 January 2019 - PDUFA action date set for 30 June 2019. ...
Posted by Michael Wonder on 06 Jan 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of sickle cell disease
4 January 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for ...