Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 31 Aug 2017
Advanced Accelerator Applications announces New Prescription Drug User Fee Act date of 26 January 2018 for Lutetium Lu 177 dotatate (Lutathera)
28 August 2017 - Advanced Accelerator Applications today announced that the US FDA has acknowledged receipt and considered complete the resubmission ...
Posted by Michael Wonder on 31 Aug 2017
FDA approves Genentech’s Actemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome
30 August 2017 - Actemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T ...
Posted by Michael Wonder on 30 Aug 2017
Novartis gene therapy approval signals new cancer treatment era
30 August 2017 - Novartis AG on Wednesday won highly anticipated U.S. approval for the first of a new type ...
Posted by Michael Wonder on 30 Aug 2017
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice
30 August 2017 - Novartis also announces innovative collaboration with the US Centers for Medicare and Medicaid Services. ...
Posted by Michael Wonder on 30 Aug 2017
FDA approval brings first gene therapy to the United States
30 August 2017 - CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukaemia. ...
Posted by Michael Wonder on 30 Aug 2017
Boehringer Ingelheim Pharmaceuticals receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases
29 August 2017 - Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA, building on 35 ...
Posted by Michael Wonder on 30 Aug 2017
FDA accepts BioMarin's pegvaliase biologics license application and grants priority review designation
29 August 2017 - BioMarin Pharmaceutical today announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 30 Aug 2017
FDA grants breakthrough therapy designation to Daiichi Sankyo’s DS-8201 for HER2-positive metastatic breast cancer
29 August 2017 - Designation based on preliminary clinical evidence highlights that DS-8201 has the potential to offer substantial clinical benefit ...
Posted by Michael Wonder on 30 Aug 2017
Prometic receives rare paediatric disease designation from U.S. FDA for its plasminogen replacement therapy
29 August 2017 - Triple designation of orphan drug, fast track status, combined with rare paediatric designation, underscores significant unmet need ...
Posted by Michael Wonder on 30 Aug 2017
Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018
30 August 2017 - Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. FDA in ...
Posted by Michael Wonder on 30 Aug 2017
UroGen Pharma receives FDA fast track designation for MitoGel for the treatment of upper tract urothelial carcinoma
29 August 2017 - UroGen Pharma today announced that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 30 Aug 2017
Abeona Therapeutics receives FDA breakthrough therapy designation for EB-101 autologous cell therapy in epidermolysis bullosa
29 August 2017 - FDA recently guided company to accelerate Phase 3 trial for EB-101 autologous cell therapy. ...
Posted by Michael Wonder on 30 Aug 2017
FDA approves new antibacterial drug
29 August 2017 - The U.S. FDA today approved Vabomere for adults with complicated urinary tract infections, including a type of ...