Blog
RSS FeedPosted 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
New drug price questions loom after Gilead's cancer purchase
29 August 2017 - Analysts say Kite’s therapy could reach $500,000 for one dose. ...
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 ...
Posted by Michael Wonder on 28 Aug 2017
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
28 August 2017 - One of the most promising new fields of science and medicine is the area of cell therapies ...
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
A new Parkinson’s drug is a long-acting version of a cheap generic. Should it cost $30,000 a year?
25 August 2017 - Adamas Pharmaceuticals had five minutes on Thursday night to feel good about its first U.S. drug ...
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
US Food and Drug Administration grants breakthrough therapy designation for mogamulizumab for the treatment of mycosis fungoides and Sézary syndrome
25 August 2017 - Kyowa Hakko Kirin today announced that U.S. FDA has granted breakthrough therapy designation status to their investigational ...
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 25 Aug 2017
Ultragenyx and Kyowa Hakko Kirin announce submission of burosumab's biologics license application in the US
24 August 2017 - Ultragenyx and Kyowa Hakko Kirin today announced that Ultragenyx has submitted a biologics license application with ...