Blog
RSS FeedPosted 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
FDA approves first cancer treatment for any solid tumour with a specific genetic feature
23 May 2017 - The U.S. FDA today granted accelerated approval to a treatment for patients whose cancers have a ...
Posted by Michael Wonder on 18 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
18 May 2017 - Keytruda is the only anti-PD-1 therapy to demonstrate superior overall survival versus chemotherapy in patients with advanced ...
Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response ...
Posted by Michael Wonder on 18 May 2017
GlycoMimetics' GMI-1271 receives FDA breakthrough therapy designation for adult relapsed/refractory acute myeloid leukaemia
17 May 2017 - GlycoMimetics today announced that the U.S. FDA has granted breakthrough therapy designation for treatment of adult relapsed/refractory ...
Posted by Michael Wonder on 16 May 2017
Ignyta granted breakthrough therapy designation for entrectinib by U.S. Food and Drug Administration
15 May 2017 - Ignyta today announced that the U.S. FDA has granted a breakthrough therapy designation to entrectinib for ...
Posted by Michael Wonder on 12 May 2017
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the ...
Posted by Michael Wonder on 11 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic non-squamous non-small-cell lung cancer, irrespective of PD-L1 expression
10 May 2017 - First approval for an anti-PD-1 therapy as a combination in metastatic non-squamous NSCLC. ...
Posted by Michael Wonder on 10 May 2017
FDA grants Bavencio (avelumab) approval for a common type of advanced bladder cancer
9 May 2017 - Second approval for Bavencio in less than two months. ...
Posted by Michael Wonder on 09 May 2017
Novartis receives FDA approval for first-of-its-kind Kisqali Femara co-pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer
8 May 2017 - Co-Pack allows patients ability to obtain Kisqali and Femara with a single co-pay. ...
Posted by Michael Wonder on 04 May 2017
Cancer drugs are getting better and dearer
4 May 2017 - AstraZeneca’s Imfinzi costs $180,000 for a year’s treatment. ...
Posted by Michael Wonder on 03 May 2017
Altor BioScience Corporation announces FDA fast track designation for lead candidate ALT-803 in patients with non-muscle invasive bladder cancer
2 May 2017 - Altor BioScience announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 02 May 2017
AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer
1 May 2017 - Approval granted regardless of PD-L1 status, based on tumour response rate and duration of response. ...
Posted by Michael Wonder on 29 Apr 2017
Myriad Genetics and Clovis Oncology sign agreement for use of FDA approved BRACAnalysis CDx test to identify patients with germline BRCA mutations for Rubraca (rucaparib) treatment
27 April 2017 - Myriad Genetics and Clovis Oncology today announced a companion diagnostic collaboration to support a post-marketing regulatory ...
Posted by Michael Wonder on 29 Apr 2017
Takeda announces FDA accelerated approval of Alunbrig (brigatinib)
29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant ...