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RSS FeedPosted by Michael Wonder on 02 Mar 2017
FDA accepts new drug application and grants priority review for enasidenib in relapsed or refractory AML with an IDH2 mutation
1 March 2017 - PDUFA date set for 30 August 2017. ...
Posted by Michael Wonder on 01 Mar 2017
Teva announces priority review granted by FDA for SD-809 for treatment of tardive dyskinesia
28 February 2017 - Teva Pharmaceutical Industries today announced the U.S. FDA has accepted the new drug application and granted ...
Posted by Michael Wonder on 01 Mar 2017
FDA accepts the biologics license application for avelumab for the treatment of metastatic urothelial carcinoma for priority review
28 February 2017 - Second biologics license application accepted by the FDA for avelumab. ...
Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ...
Posted by Michael Wonder on 02 Feb 2017
U.S. FDA grants priority review to AbbVie for its investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
2 February 2017 - The priority designation shortens the regulatory review period from the standard 10 months to six months ...
Posted by Michael Wonder on 24 Jan 2017
Roche says FDA grants priority review for Actemra
24 January 2017 - The U.S. FDA has granted priority review designation of Roche's rheumatoid arthritis medication Actemra for giant cell ...
Posted by Michael Wonder on 09 Jan 2017
FDA grants Roche’s cancer immunotherapy Tecentriq (atezolizumab) priority review in additional type of advanced bladder cancer
9 January 2017 - Second priority review granted for Tecentriq in advanced bladder cancer. ...
Posted by Michael Wonder on 04 Jan 2017
Regorafenib granted priority review in the U.S. for second-line treatment of liver cancer
4 January 2017 - Bayer today announced that the U.S. FDA has granted priority review designation to the supplemental new drug ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted 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 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 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 28 Nov 2016
FDA grants priority review to Merck’s supplemental biologics license application seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer
28 November 2016 - Merck today announced that the U.S. FDA accepted for review the supplemental biologics license application for Keytruda ...
Posted by Michael Wonder on 27 Nov 2016
Neurocrine announces Ingrezza (valbenazine) new drug application for the treatment of tardive dyskinesia has been accepted for priority review by U.S. FDA
11 October 2016 - Neurocrine Biosciences today announced that the U.S. FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 14 Nov 2016
Novartis drug PKC412 (midostaurin) granted FDA priority review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis
14 November 2016 - The AML treatment strategy has remained unchanged for more than 25 years and PKC412 (midostaurin) may ...