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RSS FeedPosted by Michael Wonder on 19 Oct 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...
Posted by Michael Wonder on 18 Oct 2017
US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review
18 October 2017 - Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer. ...
Posted by Michael Wonder on 18 Oct 2017
Radius Health receives FDA fast track designation for elacestrant (RAD1901)
18 October 2017 - Radius plans to initiate Phase 2 clinical study of elacestrant as a third-line therapy for women with ...
Posted by Michael Wonder on 17 Oct 2017
US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small-cell lung cancer
17 October 2017 - Acceptance follows FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 16 Oct 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review
16 October 2017 - Application based on results from Phase 3 CheckMate-238 study. ...
Posted by Michael Wonder on 16 Oct 2017
Exelixis announces U.S. FDA grants priority review for Cabometyx (cabozantinib) as a treatment for previously untreated advanced renal cell carcinoma
16 October 2017 - FDA assigns Prescription Drug User Fee Act action date of 15 February 2018. ...
Posted by Michael Wonder on 16 Oct 2017
Cancer drug study data was falsified, says AstraZeneca
14 October 2017 - An early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the ...
Posted by Michael Wonder on 12 Oct 2017
FDA grants priority review for potential new indication for Lilly's Verzenio (abemaciclib) as initial treatment of advanced breast cancer
12 October 2017 - Eli Lilly and Company today announced that the U.S. FDA has granted priority review designation for its ...
Posted by Michael Wonder on 12 Oct 2017
First FDA approval agnostic of cancer site — when a biomarker defines the indication
11 October 2017 - In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and paediatric patients ...
Posted by Michael Wonder on 12 Oct 2017
Janssen submits new drug application to U.S. FDA for apalutamide (ARN-509) to treat men with non-metastatic castration-resistant prostate cancer
11 October 2017 - First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk ...
Posted by Michael Wonder on 11 Oct 2017
FDA grants priority review to Gilotrif for uncommon EGFR mutations in advanced non-small-cell lung cancer
10 October 2017 - Submission is based on a meta-analysis of three LUX-Lung Phase III studies that examined Gilotrif (afatinib) in ...
Posted by Michael Wonder on 11 Oct 2017
U.S. FDA grants fast track designation to Astellas for development of gilteritinib in relapsed or refractory acute myeloid leukaemia
10 October 2017 - Astellas announced today that the U.S. FDA has granted fast track designation for the development of gilteritinib ...
Posted by Michael Wonder on 10 Oct 2017
Clovis Oncology submits supplemental new drug application for rucaparib as maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer
9 October 2017 - Company plans to file marketing authorisation application in Europe in early 2018 for maintenance treatment indication. ...
Posted by Michael Wonder on 10 Oct 2017
A flawed study depicts drug companies as profiteers
9 October 2017 - Even the authors admit their selection criteria are a ‘critical limitation.’ That’s an understatement. ...
Posted by Michael Wonder on 09 Oct 2017
Tagrisso granted breakthrough therapy designation by US FDA for the first-line treatment of patients with EGFR mutation-positive non-small cell lung cancer
9 October 2017 - Designation based on positive Phase III FLAURA trial results. ...