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RSS FeedPosted 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 25 Mar 2017
Almirall and Sun Pharma announce regulatory filing of tildrakizumab in Europe
24 March 2017 - Almirall and Sun Pharmaceutical Industries announced today the validation of the regulatory filing of tildrakizumab with ...
Posted by Michael Wonder on 24 Mar 2017
Lundbeck and Otsuka's brexpiprazole for adult patients with schizophrenia accepted for review by EMA
23 March 2017 - The EMA is expected to complete its review in second quarter of 2018. ...
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 22 Mar 2017
First anniversary of PRIME – experience so far
22 March 2017 - Registration opens for stakeholder meeting on 19 May 2017. ...
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20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting.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
EMA publishes updated list of applications for new human medicines under evaluation by the CHMP
16 March 2017 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...
Posted by Michael Wonder on 16 Mar 2017
Cardiome receives Notice of Compliance from Health Canada for its Brinavess NDS
14 March 2017 - Cardiome Pharma Corporation announced today that it received a Notice of Compliance for Brinavess (vernakalant hydrochloride, IV) ...
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 ...
Posted by Michael Wonder on 16 Mar 2017
Nine submissions done and two due by month end…
16 March 2017 - Industry advocacy at AusBiotech is in ‘top gear’ with nine submissions completed on behalf of members ...
Posted by Michael Wonder on 15 Mar 2017
Merck provides update on supplemental biologics license application for Keytruda (pembrolizumab) in previously treated advanced microsatellite instability-high cancer
14 March 2017 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics ...
Posted by Michael Wonder on 11 Mar 2017
Radius Health receives notification of PDUFA extension for abaloparatide
10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017. ...