Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2016
FDA commissioner calls for Sarepta clinical trial to be retracted
22 September 2016 - In an unusual development, the US FDA Commissioner Dr. Robert Califf has indicated that a clinical trial ...
Posted by Michael Wonder on 21 Sep 2016
FDA and access to medications
14 September 2016 - The FDA doesn’t regulate drug prices – prices are set by the drug makers or distributors. ...
Posted by Michael Wonder on 21 Sep 2016
Evaluating the FDA’s approach to cancer clinical trials
16 September 2016 - Since the announcement of the FDA Oncology Center of Excellence in June 2016 as part of the ...
Posted by Michael Wonder on 21 Sep 2016
U.S. FDA approves Invokamet XR (canagliflozin with metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes
21 September 2016 - Newest Invokana (canagliflozin) plus metformin treatment provides unique formulation option for first-line therapy. ...
Posted by Michael Wonder on 21 Sep 2016
DBV Technologies receives FDA fast track designation for Viaskin Milk for the treatment of cow’s milk protein allergy
21 September 2016 - DBV first to announce fast track designation for IgE-mediated CMPA; Viaskin Milk is currently being investigated ...
Posted by Michael Wonder on 20 Sep 2016
The boys who beat the FDA
19 September 2016 - The agency approves a new medicine after an ugly bureaucratic brawl. ...
Posted by Michael Wonder on 20 Sep 2016
Sarepta to charge $300K for Duchenne drug. ‘We tried to be reasonable,’ CEO says
19 September 2016 - The newly approved Sarepta Therapeutics drug for Duchenne muscular dystrophy will cost about $300,000 a year for ...
Posted by Michael Wonder on 20 Sep 2016
Did the FDA set ‘a dangerous precedent’ with its latest drug approval?
19 September 2016 - The experimental drug that the FDA approved Monday will only be used by a few thousand patients. ...
Posted by Michael Wonder on 20 Sep 2016
Behind the Sarepta drug approval was intense FDA bickering
19 September 2016 - The run-up to this week's approval of a Sarepta Therapeutics medicine to treat patients with Duchenne muscular ...
Posted by Michael Wonder on 20 Sep 2016
FDA approves new five-year-contraceptive of Bayer
19 September 2016 - The U.S. FDA has approved Bayer AG’s new low dose levonorgestrel-releasing intrauterine system which will be marketed ...
Posted by Michael Wonder on 19 Sep 2016
Windtree Therapeutics announces FDA fast track designation for Aerosurf
19 September 2016 - Windtree Therapeutics today announced that the U.S. FDA has granted fast track designation for Aerosurf (lucinactant for ...
Posted by Michael Wonder on 19 Sep 2016
Sellas Life Sciences receives FDA fast track designation of galinpepimut-S for the treatment of malignant pleural mesothelioma
19 September 2016 - Follows fast track designation of galinpepimut-S for the treatment of acute myeloid leukaemia. ...
Posted by Michael Wonder on 19 Sep 2016
FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
19 September 2016 - Contest seeks to stimulate development of a mobile app to connect those experiencing an overdose with the ...
Posted by Michael Wonder on 19 Sep 2016
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
19 September 2016 - The U.S. FDA today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with ...
Posted by Michael Wonder on 14 Sep 2016
FDA’s expedited programs and their impact on the availability of new therapies
7 September 2016 - The US FDA’s priority review, accelerated approval, fast track, and breakthrough therapy programs have been successful in ...