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RSS FeedPosted by Michael Wonder on 17 Apr 2020
FDA approves first targeted treatment for patients with cholangiocarcinoma, a cancer of bile ducts
17 April 2020 - Today, the U.S. FDA granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with ...
Posted by Michael Wonder on 17 Apr 2020
FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer
17 April 2020 - Today, as part of Project Orbis, the U.S. FDA approved Tukysa (tucatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 17 Apr 2020
Chi-Med announces surufatinib granted U.S. FDA fast track designations for the treatment of both pancreatic and non-pancreatic neuroendocrine tumours
17 April 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted two fast track designations for the ...
Posted by Michael Wonder on 15 Apr 2020
FDA approves first therapy for treatment of low grade upper tract urothelial cancer
15 April 2020 - Today, the U.S. FDA approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial ...
Posted by Michael Wonder on 14 Apr 2020
Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs
13 April 2020 - In July 2018, the FDA first published a table listing all surrogate measures that it has used, ...
Posted by Michael Wonder on 09 Apr 2020
Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results. ...
Posted by Michael Wonder on 08 Apr 2020
U.S. FDA approves Braftovi (encorafenib) in combination with cetuximab for the treatment of BRAF V600E mutant metastatic colorectal cancer after prior therapy
8 April 2020 - Braftovi plus cetuximab is the first and only FDA approved targeted regimen specifically for adults with previously ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Agenus receives fast track designation for balstilimab in advanced cervical cancer
7 April 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...
Posted by Michael Wonder on 08 Apr 2020
FDA grants fast track designation to sacituzumab govitecan for urothelial cancer
7 April 2020 - Immunomedics today announced that the U.S. FDA has granted fast track designation for sacituzumab govitecan for the ...
Posted by Michael Wonder on 07 Apr 2020
Blaze Bioscience announces FDA has granted fast track designation to BLZ-100 (tozuleristide) for paediatric central nervous system tumours
7 April 2020 - Phase 2/3 pivotal trial ongoing in patients up to 30 years of age undergoing surgery for paediatric ...
Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who ...
Posted by Michael Wonder on 02 Apr 2020
Y-mAbs announces submission of naxitamab biologics license application to U.S. FDA
1 April 2020 - Y-mAbs Therapeutics today announced that the Company has completed the submission of its biologics license application under ...
Posted by Michael Wonder on 01 Apr 2020
Aveo Oncology announces submission of new drug application to U.S. FDA for tivozanib in patients with relapsed or refractory renal cell carcinoma
31 March 2020 - Aveo Oncology today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Apr 2020
MEI Pharma announces fast track designation granted by U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma
31 March 2020 - MEI Pharma today announced that the U.S. FDA granted fast track designation to ME-401, MEI's investigational selective ...