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RSS FeedPosted by Michael Wonder on 01 Jun 2017
Jazz Pharmaceuticals announces FDA acceptance of NDA for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia, with priority review status
31 May 2017 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 31 May 2017
ProQR receives fast track designation from the FDA for QR-110 for Leber’s congenital amaurosis type 10
31 May 2017 - QR-110 is currently in clinical development with the planned Phase 1/2 open-label trial (PQ-110-001) that will assess ...
Posted by Michael Wonder on 31 May 2017
Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
31 May 2017 - These regulatory submissions follow soon after two positive CHMP opinions for Sandoz biosimilars etanercept and rituximab further ...
Posted by Michael Wonder on 31 May 2017
Indivior submits new drug application to U.S. FDA for RBP-6000 buprenorphine monthly depot
30 May 2017 - A potential novel long-acting, sustained release product candidate for treatment of opioid use disorder. ...
Posted by Michael Wonder on 30 May 2017
AMO Pharma announces FDA fast track designation for AMO-02 for treatment of congenital myotonic dystrophy
30 May 2017 - AMO Pharma Limited today announced that the U.S. FDA has granted fast track designation for AMO-02, the ...
Posted by Michael Wonder on 30 May 2017
Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba label
27 May 2017 - Novo Nordisk today announced the submission of a supplemental application to the US FDA for including ...
Posted by Michael Wonder on 28 May 2017
Sunovion announces FDA filing acceptance of new drug application for SUN-101/eFlow for the treatment of patients with chronic obstructive pulmonary disease
13 October 2016 - SUN-101/eFlow (glycopyrrolate) NDA is currently under review; if approved, it would represent the first available nebulised ...
Posted by Michael Wonder on 28 May 2017
U.S. FDA accepts for review supplemental new drug application for Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 to 17 years of age
22 May 2017 - If approved, Aptiom would provide an important monotherapy or adjunctive therapy treatment option for pediatric patients who ...
Posted by Michael Wonder on 28 May 2017
Kite receives U.S. Food and Drug Administration priority review for axicabtagene ciloleucel
26 May 2017 - Biologics license application submission based on the primary analysis of the ZUMA-1 Phase 2 trial. ...
Posted by Michael Wonder on 28 May 2017
Sunovion receives complete response letter from FDA for SUN-101/eFlow (glycopyrrolate) new drug application for chronic obstructive pulmonary disease
26 May 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 26 May 2017
CalciMedica receives fast-track designation for CM4620, a novel CRAC channel inhibitor to treat acute pancreatitis
24 May 2017 - Patient studies expected to begin in 2018. ...
Posted by Michael Wonder on 24 May 2017
U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated hepatocellular carcinoma
24 May 2017 - Application is based on results from the Phase 1/2 CheckMate-040 trial. ...
Posted by Michael Wonder on 24 May 2017
Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
Posted by Michael Wonder on 23 May 2017
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma
23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting. ...
Posted by Michael Wonder on 23 May 2017
Fujifilm Kyowa Kirin Biologics announces marketing authorisation application for FKB327 accepted for review by European Medicines Agency
22 May 2017 - Fujifilm Kyowa Kirin Biologics announces that on May 18, 2017, the EMA has accepted for review the ...