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RSS FeedPosted by Michael Wonder on 08 Jun 2017
Mateon Therapeutics receives FDA fast track designation for OXI4503 in patients with acute myeloid leukaemia
7 June 2017 - Mateon Therapeutics today announced that the U.S. FDA has granted fast track designation to the company's product ...
Posted by Michael Wonder on 07 Jun 2017
Calithera Biosciences announces FDA fast track designation granted to CB-839 for treatment of patients with renal cell carcinoma
Calithera Biosciences today announced that the U.S. FDA has granted fast track designation to CB-839 in combination with everolimus, for ...
Posted by Michael Wonder on 06 Jun 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) regimen receives expanded FDA approval in unresectable or metastatic melanoma across BRAF status
23 January 2016 - Opdivo + Yervoy regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, ...
Posted by Michael Wonder on 06 Jun 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) is the first immuno-oncology treatment to receive FDA approval based on overall survival in head and neck cancer
10 November 2016 - Opdivo is the first and only immuno-oncology treatment proven in a Phase 3 trial to significantly extend ...
Posted by Michael Wonder on 05 Jun 2017
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) as extended treatment for recurrent or progressive CLL
19 January 2016 - Arzerra previously approved to treat previously untreated and refractory chronic lymphocytic leukaemia indications in the US. ...
Posted by Michael Wonder on 04 Jun 2017
Merck receives accelerated approval of Keytruda (pembrolizumab), the first FDA approved anti-PD-1 therapy
4 September 2014 - Merck today announced that the US FDA has approved Keytruda (pembrolizumab) at a dose of 2 ...
Posted by Michael Wonder on 04 Jun 2017
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma
18 December 2015 - Keytruda is now the first and only anti-PD-1 therapy to achieve superior overall survival compared to ipilimumab. ...
Posted by Michael Wonder on 04 Jun 2017
FDA approves Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy
5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death ...
Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
Posted by Michael Wonder on 01 Jun 2017
More new cancer drugs mean higher costs but also longer lives
1 June 2017 - Spending on cancer treatments has spiked past the $100 billion mark globally over the past five ...
Posted 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 29 May 2017
Designing clinical trials that accept new arms: an example in metastatic breast cancer
22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against ...
Posted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with ...
Posted by Michael Wonder on 25 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient cancer
23 May 2017 - Keytruda now approved for patients with MSI-H or mismatch repair deficient solid tumours that have progressed following ...
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. ...