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RSS FeedPosted 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
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
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 ...
Posted by Michael Wonder on 30 Aug 2017
FDA grants breakthrough therapy designation for MDMA-assisted psychotherapy for PTSD, agrees on special protocol assessment for phase 3 trials
26 August 2017 - Breakthrough therapy designation ensures that FDA will work closely with MAPS to complete Phase 3 trials as ...
Posted by Michael Wonder on 29 Aug 2017
U.S. FDA and EMA accept regulatory submissions for Bosulif (bosutinib) for the treatment of patients with newly diagnose Ph+ chronic myeloid leukaemia
29 August 2017 - Applications seek to expand approved use of Bosulif into first- line treatment based on positive results from ...
Posted by Michael Wonder on 29 Aug 2017
FDA approves first U.S. treatment for Chagas disease
29 August 2017 - The U.S. FDA today granted accelerated approval to benznidazole for use in children ages 2 to 12 ...
Posted by Michael Wonder on 29 Aug 2017
Acorda receives refusal to file letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) new drug application
29 August 2017 - Acorda Therapeutics today announced that it received a refusal to file letter from the U.S. FDA ...
Posted by Michael Wonder on 29 Aug 2017
La Jolla Pharmaceutical Company announces U.S. FDA acceptance of new drug application for LJPC-501
28 August 2017 - Priority review granted. ...
Posted by Michael Wonder on 28 Aug 2017
FDA grants priority review for Genentech’s Gazyva in previously untreated follicular lymphoma
27 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...