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RSS FeedPosted 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 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 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 28 Aug 2017
Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer
28 August 2017 - 20% reduction in disease progression vs anastrozole, a current standard treatment option. ...
Posted by Michael Wonder on 28 Aug 2017
Kedrion Biopharma and Kamada receive FDA approval of Kedrab for post-exposure prophylaxis against rabies infection
25 August 2017 - Approval of Kedrab is based on positive data from a prospective, randomised, double-blind, non-inferiority Phase 2/3 study ...
Posted by Michael Wonder on 27 Aug 2017
Victoza approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events
25 August 2017 - The U.S. FDA has approved a new indication for Victoza (liraglutide) to reduce the risk of major ...
Posted by Michael Wonder on 25 Aug 2017
Adamas announces FDA approval of Gocovri as first and only medication for the treatment of dyskinesia in Parkinson's disease patients
24 August 2017 - Adamas Pharmaceuticals today announced that the U.S. FDA has approved Gocovri (amantadine) extended release capsules for treatment ...
Posted by Michael Wonder on 24 Aug 2017
Octapharma USA announces FDA approval of Nuwiq new product strengths, expanding haemophilia A patient treatment options
22 August 2017 - New higher vial strengths will provide added dosing flexibility & convenience. ...
Posted by Michael Wonder on 17 Aug 2017
Lynparza receives additional and broad approval in the US for ovarian cancer
17 August 2017 - Newly-approved tablet formulation means improved patient convenience. ...
Posted by Michael Wonder on 17 Aug 2017
FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukaemia
17 August 2017 - The U.S. FDA today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or ...
Posted by Michael Wonder on 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...
Posted by Michael Wonder on 10 Aug 2017
FDA issues a complete response letter on CCP-08 NDA
7 August 2017 - Vernalis announced today that the US FDA has issued a complete response letter regarding the new ...