Blog
RSS FeedPosted by Michael Wonder on 19 May 2017
Sage Therapeutics receives fast track designation for SAGE-217 for the treatment of major depressive disorder
18 May 2017 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-217 for ...
Posted by Michael Wonder on 18 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
18 May 2017 - Keytruda is the only anti-PD-1 therapy to demonstrate superior overall survival versus chemotherapy in patients with advanced ...
Posted by Michael Wonder on 18 May 2017
Clinical trial participants should have a say in new drug pricing
18 May 2017 - People who volunteer to participate in clinical trials of new drugs provide a valuable service to ...
Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response ...
Posted by Michael Wonder on 18 May 2017
GlycoMimetics' GMI-1271 receives FDA breakthrough therapy designation for adult relapsed/refractory acute myeloid leukaemia
17 May 2017 - GlycoMimetics today announced that the U.S. FDA has granted breakthrough therapy designation for treatment of adult relapsed/refractory ...
Posted by Michael Wonder on 17 May 2017
How patients are changing clinical trials
17 May 2017 - In September, the FDA approved a controversial drug to treat Duchenne muscular dystrophy, a rare but deadly ...
Posted by Michael Wonder on 17 May 2017
FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis
17 May 2017 - The U.S. FDA today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. ...
Posted by Michael Wonder on 17 May 2017
Sangamo receives fast track designation from the FDA for SB-525 investigational haemophilia A gene therapy
16 May 2017 - Sangamo Therapeutics announced today that the U.S. FDA has granted fast track designation to SB-525, the Company's ...
Posted by Michael Wonder on 16 May 2017
Dr. Gottlieb’s first remarks to FDA staff
15 May 2017 - It’s an honor to be here today, and to be taking on this responsibility with all ...
Posted by Michael Wonder on 16 May 2017
Reducing preventable harm from medications: too big for FDA to do alone
16 May 2017 - Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor ...
Posted by Michael Wonder on 16 May 2017
Aerie Pharmaceuticals announces FDA acceptance of NDA submission for Rhopressa (netarsudil ophthalmic solution) 0.02%
15 May 2017 - PDUFA date set for 28 February 2018. ...
Posted by Michael Wonder on 16 May 2017
Ignyta granted breakthrough therapy designation for entrectinib by U.S. Food and Drug Administration
15 May 2017 - Ignyta today announced that the U.S. FDA has granted a breakthrough therapy designation to entrectinib for ...
Posted by Michael Wonder on 16 May 2017
Imara receives rare paediatric disease designation from FDA for lead product candidate IMR-687 for sickle cell disease
15 May 2017 - Imara announced today that the U.S. FDA has granted rare paediatric disease designation to IMR-687, the ...
Posted by Michael Wonder on 16 May 2017
Biohaven's trigriluzole receives fast track designation from U.S. FDA
15 May 2017 - Potential first-in-class therapy for spinocerebellar ataxia. ...
Posted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...