Blog
RSS FeedPosted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes. ...
Posted by Michael Wonder on 27 Jul 2017
Priority review vouchers for tropical disease drugs simply aren’t working
25 July 2017 - A controversial program created by Congress to spur development of new drugs for neglected tropical diseases ...
Posted by Michael Wonder on 26 Jul 2017
Orchard Therapeutics announces that OTL-101 has received a rare paediatric disease designation
25 July 2017 - Orchard Therapeutics is delighted to announce today that the US FDA granted a rare paediatric disease designation ...
Posted by Michael Wonder on 19 Jul 2017
U.S. FDA designates Mallinckrodt's StrataGraft as regenerative medicine advanced therapy
18 July 2017 - Provides potential for priority review and accelerated approval under 21st Century Cures Act. ...
Posted by Michael Wonder on 19 Jul 2017
Capricor receives rare paediatric disease designation from FDA for CAP-1002 for patients with Duchenne muscular dystrophy
18 July 2017 - Designation covers broad treatment of Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 18 Jul 2017
Spark Therapeutics’ biologics license application for investigational voretigene neparvovec accepted for filing by FDA
17 July 2017 - FDA grants priority review with PDUFA date of 12 January 2018. ...
Posted by Michael Wonder on 10 Jul 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Sprycel (dasatinib) in children with Philadelphia chromosome positive chronic phase chronic myeloid leukaemia
10 July 2017 - Application is based on results from Phase 2 CA180-226 study. ...
Posted by Michael Wonder on 10 Jul 2017
FDA grants priority review for Lilly's abemaciclib for the treatment of advanced breast cancer
10 July 2017 - Eli Lilly and Company (NYSE: LLY) today announced that the U.S. FDA has accepted and filed its ...
Posted by Michael Wonder on 04 Jul 2017
Amphora (L-lactic acid, citric acid, and potassium bitartrate) receives QIDP designation from the FDA
29 June 2017 - Designation includes two separate indications and provides eligibility for priority review and additional exclusivity. ...
Posted by Michael Wonder on 01 Jul 2017
FDA grants priority review to HIV monoclonal antibody and long-acting investigational anti-retroviral ibalizumab
30 June 2017 - Biologics license application accepted for review with a target action date of 3 January 2018. ...
Posted by Michael Wonder on 18 Jun 2017
Fibrocell receives rare paediatric disease designation from FDA for FCX-013 for treatment of localised scleroderma
12 June 2017 - Gene therapy candidate under control of RheoSwitch therapeutic system technology is potential first-in-class treatment for chronic ...
Posted by Michael Wonder on 06 Jun 2017
BioCryst announces Rapivab paediatric sNDA acceptance
5 June 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
Posted by Michael Wonder on 01 Jun 2017
Jazz Pharmaceuticals announces FDA acceptance of NDA for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia, with priority review status
31 May 2017 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 28 May 2017
Kite receives U.S. Food and Drug Administration priority review for axicabtagene ciloleucel
26 May 2017 - Biologics license application submission based on the primary analysis of the ZUMA-1 Phase 2 trial. ...