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RSS FeedPosted by Michael Wonder on 13 Nov 2017
Fortress Biotech announces Cellvation's CEVA101 granted FDA regenerative medicine advanced therapy designation for the treatment of traumatic brain injury
8 November 2017 - CEVA101 is being developed in partnership with The University of Texas Health Science Center at Houston. ...
Posted by Michael Wonder on 28 Oct 2017
AbbVie receives U.S. FDA priority review for investigational oral treatment elagolix for the management of endometriosis with associated pain
27 October 2017 - If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain ...
Posted by Michael Wonder on 18 Oct 2017
US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review
18 October 2017 - Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer. ...
Posted by Michael Wonder on 17 Oct 2017
US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small-cell lung cancer
17 October 2017 - Acceptance follows FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 16 Oct 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review
16 October 2017 - Application based on results from Phase 3 CheckMate-238 study. ...
Posted by Michael Wonder on 16 Oct 2017
Exelixis announces U.S. FDA grants priority review for Cabometyx (cabozantinib) as a treatment for previously untreated advanced renal cell carcinoma
16 October 2017 - FDA assigns Prescription Drug User Fee Act action date of 15 February 2018. ...
Posted by Michael Wonder on 12 Oct 2017
FDA grants priority review for potential new indication for Lilly's Verzenio (abemaciclib) as initial treatment of advanced breast cancer
12 October 2017 - Eli Lilly and Company today announced that the U.S. FDA has granted priority review designation for its ...
Posted by Michael Wonder on 11 Oct 2017
FDA grants priority review to Gilotrif for uncommon EGFR mutations in advanced non-small-cell lung cancer
10 October 2017 - Submission is based on a meta-analysis of three LUX-Lung Phase III studies that examined Gilotrif (afatinib) in ...
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 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 29 Sep 2017
FDA grants priority review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
29 September 2017 - Roche today announced the US FDA has accepted the company’s supplemental biologics license application and granted priority ...
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
Camurus announces that FDA grants priority review of NDA for weekly and monthly CAM2038 buprenorphine depots for treatment of opioid use disorder
18 September 2017 - Camurus announces that the U.S. FDA has accepted the new drug application for weekly and monthly CAM2038 ...
Posted by Michael Wonder on 24 Sep 2017
Generics industry calls FDA draft guidance on priority reviews 'basically inoperable'
22 September 2017 - A generic drug industry group and several companies have taken issue with recent US FDA draft ...
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. ...