Blog
RSS FeedPosted by Michael Wonder on 02 Apr 2017
Kite completes submission of U.S. biologics license application for axicabtagene ciloleucel as the first CAR-T therapy for the treatment of patients with aggressive non-Hodgkin lymphoma
31 March 2017 - Kite is preparing for potential approval and launch for axicabtagene ciloleucel in 2017. ...
Posted by Michael Wonder on 31 Mar 2017
Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the US
29 March 2017 - Novo Nordisk today announced that the company has resubmitted the new drug application for fast-acting insulin ...
Posted by Michael Wonder on 30 Mar 2017
U.S. FDA approves addition of moderate to severe fingernail psoriasis data to AbbVie's Humira (adalimumab) prescribing information
30 March 2017 - Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis. ...
Posted by Michael Wonder on 30 Mar 2017
FDA grants priority review for Amgen's Blincyto (blinatumomab) supplemental biologics license application
29 March 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 29 Mar 2017
Mylan comments on generic Advair Diskus abbreviated new drug application
29 March 2017 - Mylan today commented on the status of its abbreviated new drug application with the U.S. FDA ...
Posted by Michael Wonder on 29 Mar 2017
Novartis announces first CAR-T cell therapy BLA for paediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review
29 March 2017 - Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using ...
Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 ...
Posted by Michael Wonder on 28 Mar 2017
FDA grants priority review for Eagle Pharmaceuticals’ Ryanodex NDA for the treatment of exertional heat stroke
27 March 2017 - Eagle Pharmaceuticals announced today that their 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment ...
Posted by Michael Wonder on 25 Mar 2017
Symbiomix Therapeutics announces FDA’s acceptance of new drug application for Solosec with priority review status
23 March 2017 - Symbiomix today announced that the US FDA has accepted for filing the Company’s new drug application for ...
Posted by Michael Wonder on 23 Mar 2017
Shire receives FDA fast track designation for recombinant ADAMTS13 (SHP655) for treatment of hereditary thrombotic thrombocytopenic purpura
22 March 2017 - Shire today announced that the United States FDA has granted fast track designation for recombinant ADAMTS13 (SHP655 ...
Posted by Michael Wonder on 21 Mar 2017
Humacyte receives FDA regenerative medicine advanced therapy expedited review designation for Humacyl in vascular access for haemodialysis
20 March 2017 - Humacyte announced today that the U.S. FDA has granted Humacyl, its investigational human acellular vessel, the ...
Posted by Michael Wonder on 20 Mar 2017
Array BioPharma provides update on FDA submission for binimetinib
20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting. ...
Posted by Michael Wonder on 18 Mar 2017
AstraZeneca receives complete response letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
17 March 2017 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 16 Mar 2017
Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older
15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...