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RSS FeedPosted 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 15 Sep 2016
Shire announces U.S. FDA approval of Cuvitru [immune globulin (human), 20% solution for subcutaneous injection] treatment for primary immunodeficiency
14 September 2016 - Approval follows positive data from clinical studies on efficacy and tolerability, as well as infusion time and ...
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 ...
Posted by Michael Wonder on 13 Sep 2016
Aptinyx receives FDA fast track designation for development of NYX-2925 as treatment for neuropathic pain associated with diabetic peripheral neuropathy
13 September 2016 - Data from pre-clinical investigation of NYX-2925 to be presented at 16th World Congress on Pain on ...
Posted by Michael Wonder on 13 Sep 2016
FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness
13 September 2016 - The U.S. FDA today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure ...
Posted by Michael Wonder on 12 Sep 2016
Tesaro receives FDA fast track designation for niraparib and initiates rolling NDA submission
12 September 2016 - Tesaro today announced that the U.S. FDA has granted fast track designation to niraparib for the treatment ...
Posted by Michael Wonder on 07 Sep 2016
Sage receives FDA breakthrough therapy designation for SAGE-547 for the treatment of postpartum depression
6 September 2016 - Designation offers potential for expedited development and review, and underscores significant unmet need in women with postpartum ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 07 Sep 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
6 September 2016 - This study, published in JAMA, uses US FDA data to identify approved generic drugs manufactured between September ...
Posted by Michael Wonder on 03 Sep 2016
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
2 September 2016 - The U.S. FDA today allowed marketing of two Trevo clot retrieval devices as an initial therapy for ...