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RSS FeedPosted by Michael Wonder on 12 Oct 2017
U.S. FDA accepts for review Astellas’ supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
12 September 2017 - If approved, the combination therapy could potentially offer a new treatment option for patients whose overactive ...
Posted by Michael Wonder on 11 Oct 2017
Ultragenyx and Kyowa Hakko Kirin announce FDA acceptance and priority review designation of burosumab's biologics license application
10 October 2017 - Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International today announce that the U.S. FDA has accepted the ...
Posted by Michael Wonder on 10 Oct 2017
Clovis Oncology submits supplemental new drug application for rucaparib as maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer
9 October 2017 - Company plans to file marketing authorisation application in Europe in early 2018 for maintenance treatment indication. ...
Posted by Michael Wonder on 10 Oct 2017
FDA accepts supplemental biologics license application for Prolia (denosumab) in glucocorticoid-induced osteoporosis
9 October 2017 - Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis. ...
Posted by Michael Wonder on 04 Oct 2017
Expanded access: FDA describes efforts to ease application process
3 October 2017 - FDA has a long history of supporting patient access to investigational new treatments. ...
Posted by Michael Wonder on 04 Oct 2017
FDA accepts supplemental new drug application filing for Avycaz (ceftazidime and avibactam)
2 October 2017 - Application seeks to expand label to include an indication and phase 3 data for the treatment of ...
Posted by Michael Wonder on 03 Oct 2017
Sucampo Pharmaceuticals announces FDA acceptance of sNDA for Amitiza in children with paediatric functional constipation, with priority review designation
28 September 2017 - Sucampo Pharmaceuticals today announced that the U.S. FDA has accepted for filing its recently submitted supplemental ...
Posted by Michael Wonder on 03 Oct 2017
Indivior submits new drug application to U.S. FDA for RBP-7000 risperidone monthly depot for treatment of schizophrenia
2 October 2017 - Enters into agreement with Durect to expand patent estate for RBP-7000. ...
Posted by Michael Wonder on 27 Sep 2017
Application for additional indication of Lenvima for hepatocellular carcinoma accepted for review by U.S. FDA
27 September 2017 - Eisai has announced that the application submitted for an additional indication of its in-house discovered and ...
Posted by Michael Wonder on 26 Sep 2017
Aradigm announces FDA acceptance of NDA for Linhaliq with priority review status
25 September 2017 - Aradigm today announced that the U.S. FDA has accepted for filing with priority review its new ...
Posted by Michael Wonder on 25 Sep 2017
Intellipharmaceutics receives complete response letter from the FDA for Rexista NDA
25 September 2017 - FDA response provides path toward commercialisation of Rexista. ...
Posted by Michael Wonder on 24 Sep 2017
Allergan receives refusal to file letter from FDA for Vraylar (cariprazine) supplemental new drug application for the treatment of negative symptoms in schizophrenia
22 September 2017 - Allergan today announced that it received a refusal to file letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 23 Sep 2017
Janssen receives complete response letter from U.S. FDA for sirukumab biologics license application
22 September 2017 - Janssen Biotech announced today that it has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 19 Sep 2017
FDA acceptance of NDA for CAM2038 for opioid use disorder
18 September 2017 - The FDA has assigned a Prescription Drug User Fee Act target date of 19 January 2018. ...
Posted by Michael Wonder on 18 Sep 2017
Janssen submits supplemental new drug application to U.S. FDA for Zytiga (abiraterone acetate) to treat men with earlier stages of metastatic prostate cancer
14 September 2017 - Filing supported by data from pivotal LATITUDE trial evaluating Zytiga in combination with prednisone and androgen deprivation ...