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RSS FeedPosted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 ...
Posted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for ...
Posted by Michael Wonder on 20 Dec 2016
ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA
19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license ...
Posted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not ...
Posted by Michael Wonder on 18 Dec 2016
Janssen submits application seeking FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis
16 December 2016 - Janssen Biotech announced today the submission of a supplemental biologics license application to the U.S. FDA seeking ...
Posted by Michael Wonder on 12 Dec 2016
Flexion Therapeutics submits new drug application for Zilretta to treat knee osteoarthritis pain
12 December 2016 - Flexion Therapeutics today announced it has submitted a new drug application to the U.S. FDA for its ...
Posted by Michael Wonder on 11 Dec 2016
Gilead submits new drug application to U.S. FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir
8 December 2016 - If approved, SOF/VEL/VOX would be the first once daily single tablet regimen available as a salvage ...
Posted by Michael Wonder on 09 Dec 2016
US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
9 December 2016 - FDA grants priority review status with PDUFA set for Q2 2017. ...
Posted by Michael Wonder on 07 Dec 2016
Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes
5 December 2016 - Novo Nordisk today announced the submission of a new drug application to the US FDA and ...
Posted by Michael Wonder on 06 Dec 2016
Kite Pharma initiates rolling submission of U.S. biologics license application for KTE-C19, its investigational anti-CD19 CAR-T therapy, for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma
4 December 2016 - First CAR-T therapy BLA filing initiated with the U.S. FDA. ...
Posted by Michael Wonder on 01 Dec 2016
U.S. FDA accepts for review a supplemental new drug application to expand labelling of Abilify Maintena (aripiprazole) for the treatment of bipolar I disorder
30 November 2016 - Application seeks to expand Abilify Maintena label to include maintenance treatment for bipolar I disorder. ...
Posted by Michael Wonder on 01 Dec 2016
FDA grants priority review to supplemental biologics license application for Merck’s Keytruda (pembrolizumab) in relapsed or refractory classical Hodgkin's lymphoma
1 December 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental biologics license application ...
Posted by Michael Wonder on 01 Dec 2016
Emmaus Life Sciences receives notice of FDA PDUFA date for investigational L-glutamine treatment for sickle cell disease
29 November 2016 - Emmaus Life Sciences announced today that the U.S. FDA has set a PDUFA date of 7 ...
Posted by Michael Wonder on 29 Nov 2016
FDA accepts the biologics license application for avelumab for the treatment of metastatic Merkel cell carcinoma for priority review
29 November 2016 - Avelumab has previously received FDA breakthrough therapy and fast track designations for metastatic Merkel cell carcinoma, ...
Posted by Michael Wonder on 29 Nov 2016
Epizyme announces fast track designation for tazemetostat in DLBCL and provides solid tumour program update
28 November 2016 - FDA grants tazemetostat fast track designation for DLBCL with EZH2 activating mutations. ...