Blog
RSS FeedPosted by Michael Wonder on 16 Apr 2018
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) combination as first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma
16 April 2018 - The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall ...
Posted by Michael Wonder on 15 Apr 2018
Cutting-edge cancer drug hobbled by diagnostic test confusion
9 April 2018 - Physicians struggle to identify which patients are likely to respond to a recently approved therapy. ...
Posted by Michael Wonder on 13 Apr 2018
Rhizen Pharmaceuticals receives FDA fast track designation for tenalisib (RP6530), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed and/or refractory cutaneous T-cell lymphoma
13 April 2018 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for tenalisib, the Company’s ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 12 Apr 2018
Demand cancer drugs that truly help patients
10 April 2018 - Already this year, the US FDA has approved or extended the use of several cancer drugs ...
Posted by Michael Wonder on 11 Apr 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with penta-refractory multiple myeloma
10 April 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s lead, ...
Posted by Michael Wonder on 09 Apr 2018
FDA accepts new drug application for duvelisib and grants priority review
9 April 2018 - Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic ...
Posted by Michael Wonder on 07 Apr 2018
Rubraca (rucaparib) approved in the U.S. as maintenance treatment of recurrent ovarian cancer
6 April 2018 - Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy. ...
Posted by Michael Wonder on 29 Mar 2018
FDA expands approval of Blincyto for treatment of a type of leukaemia in patients who have a certain risk factor for relapse
29 March 2018 - The U.S. FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor ...
Posted by Michael Wonder on 27 Mar 2018
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for previously treated patients with MSI-H or dMMR metastatic colorectal cancer for priority review
27 March 2018 - The FDA also granted the Opdivo plus Yervoy combination breakthrough therapy designation for this potential indication. ...
Posted by Michael Wonder on 27 Mar 2018
Bayer announces completion of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancer
26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new ...
Posted by Michael Wonder on 26 Mar 2018
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer
26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 20 Mar 2018
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
20 March 2018 - The U.S. FDA today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage ...