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RSS FeedPosted by Michael Wonder on 26 Oct 2016
Portola Pharmaceuticals submits new drug application to U.S. FDA for betrixaban for extended duration prophylaxis of venous thromboembolism in acute medically ill patients
25 October 2016 - Betrixaban, an FDA fast track-designated therapy, would be first anti-coagulant for hospital to home prevention of ...
Posted by Michael Wonder on 24 Oct 2016
GSK announces US regulatory submission of candidate vaccine for prevention of shingles
24 October 2016 - Regulatory submissions in the EU and Canada remain on track for 2016. ...
Posted by Michael Wonder on 21 Oct 2016
U.S. FDA accepts for priority review the supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer
21 October 2016 - Submission based on results from Phase 2 study CheckMate-275 evaluating Opdivo in patients with previously treated platinum-refractory ...
Posted by Michael Wonder on 21 Oct 2016
Teva announces FDA acceptance of resubmitted new drug application for SD-809 for treatment of chorea associated with Huntington disease
20 October 2016 - Teva Pharmaceutical Industries Ltd today announced that the U.S. FDA has accepted the resubmission of the ...
Posted by Michael Wonder on 18 Oct 2016
FDA accepts for review new drug application for sodium zirconium cyclosilicate for the treatment of hyperkalaemia
18 October 2016 - AstraZeneca today announced that the US FDA has accepted a complete re-submission of a new drug ...
Posted by Michael Wonder on 09 Oct 2016
Coherus Biosciences announces FDA acceptance of 351(K) biologics license application to U.S. FDA for CHS-1701 (pegfilgrastim biosimilar candidate)
6 October 2016 - Coherus BioSciences today announced that the U.S. FDA has accepted the filing of 351(k) biologics license ...
Posted by Michael Wonder on 26 Sep 2016
Biogen completes rolling submission of new drug application to FDA for nusinersen as a treatment for spinal muscular atrophy
26 September 2016 - Submission of marketing authorization application to the EMA planned in the coming weeks. ...
Posted by Michael Wonder on 26 Sep 2016
Sanofi and Regeneron announce dupilumab biologics license application accepted for priority review by U.S. FDA
26 September 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the biologics ...
Posted by Michael Wonder on 26 Sep 2016
AbbVie announces submission of a supplemental new drug application for Ibrutinib (imbruvica) for treatment of marginal zone lymphoma
26 September 2016 - If approved by the U.S. FDA, ibrutinib will be the first therapy specifically approved for patients with ...
Posted by Michael Wonder on 26 Sep 2016
Janssen submits application seeking approval of sirukumab in United States for rheumatoid arthritis
23 September 2016 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 12 Sep 2016
Tesaro receives FDA fast track designation for niraparib and initiates rolling NDA submission
12 September 2016 - Tesaro today announced that the U.S. FDA has granted fast track designation to niraparib for the treatment ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 01 Sep 2016
FDA accepts Mitsubishi Tanabe Pharma’s NDA filing for edaravone to treat ALS
30 August 2016 - Edaravone may be the first ALS treatment approved in U.S. in more than 20 years. ...
Posted by Michael Wonder on 01 Sep 2016
ARIAD completes rolling submission of new drug application for brigatinib to the U.S. FDA
30 August 2016 - ARIAD Pharmaceuticals today announced it has completed the rolling submission of the new drug application for its ...
Posted by Michael Wonder on 31 Aug 2016
Neurocrine submits new drug application for valbenazine for treatment of tardive dyskinesia
29 August 2016 - Neurocrine Biosciences today announced that it has submitted a new drug application to the U.S. FDA for ...