Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2017
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
3 July 2017 - Today, the U.S. FDA cleared the expanded use of a cooling cap, DigniCap Cooling System, to ...
Posted by Michael Wonder on 02 Jul 2017
Fears over a medical gold rush in cancer drug race
3 July 2017 - With almost 800 trials under way observers warn scientific rigour is being compromised. ...
Posted by Michael Wonder on 30 Jun 2017
FDA approves Vectibix (panitumumab) for use in wild type RAS metastatic colorectal cancer
29 June 2017 - Approved companion diagnostic tool strengthens precision medicine approach. ...
Posted by Michael Wonder on 29 Jun 2017
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first ...
Posted by Michael Wonder on 26 Jun 2017
The FDA has never approved a drug like this in its 111 year history
25 June 2017 - This cancer drug produced data so incredible that the FDA approved it immediately for a specific genetic ...
Posted by Michael Wonder on 22 Jun 2017
Novartis combination targeted therapy Tafinlar and Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small-cell lung cancer
22 June 2017 - Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 22 Jun 2017
FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certain blood cancers
22 June 2017 - Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous ...
Posted by Michael Wonder on 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...
Posted by Michael Wonder on 20 Jun 2017
FDA to clear path for drugs aimed at cancer causing genes
21 June 2017 - FDA Commissioner Gottlieb talks about push before Senate panel. ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 17 Jun 2017
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
16 June 2017 - Darzelax (daratumumab) approved by U.S. FDA in combination with pomalidomide and dexamethasone for patients with multiple myeloma ...
Posted by Michael Wonder on 09 Jun 2017
Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the US FDA
22 December 2014 - First approval of Opdivo in the US. ...
Posted by Michael Wonder on 08 Jun 2017
Burtomab receives breakthrough therapy designation for advanced form of paediatric cancer
7 June 2017 - Burtomab, a drug for metastatic neuroblastoma, has been granted breakthrough therapy designation by the FDA for the ...
Posted by Michael Wonder on 08 Jun 2017
FDA expands approved use of Opdivo to treat lung cancer
4 March 2015 - The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat ...
Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb receives approval from the US FDA for the Opdivo (nivolumab) + Yervoy (ipilimumab) regimen in BRAF V600 wild-type unresectable or metastatic melanoma
30 September 2015 - First and only FDA approved combination of two immuno-oncology agents. ...