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RSS FeedPosted by Michael Wonder on 29 Apr 2016
FDA grants Advaxis fast track designation for ADXS-HER2 for patients with newly-diagnosed, non-metastatic osteosarcoma
28 April 2016 - Advaxis today announced that the FDA has granted Fast Track Designation for the company’s immunotherapy product candidate ...
Posted by Michael Wonder on 26 Apr 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
25 April 2016 - Bristol-Myers Squibb Company announced today that the FDA has granted breakthrough therapy designation to Opdivo for the ...
Posted by Michael Wonder on 26 Apr 2016
Exelixis announces FDA approval of Cabometyx (cabozantinib maleate) tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
26 April 2016 - Exelixis today announced that the U.S. FDA has approved Cabometyx (cabozantinib maleate) tablets for the treatment of ...
Posted by Michael Wonder on 18 Apr 2016
Merck receives breakthrough therapy designation from U.S. FDA for Keytruda (pembrolizumab) in classical Hodgkin's lymphoma
18 April 2016 - Merck today announced that the U.S. FDA has granted breakthrough therapy designation to Keytruda (pembrolizumab), the company’s ...
Posted by Michael Wonder on 18 Apr 2016
FDA approves Gilotrif (afatinib dimaleate) as new oral treatment option for patients with squamous cell carcinoma of the lung
15 April 2016 - Boehringer Ingelheim today announced that the U.S. FDA has approved a supplemental New Drug Application (sNDA) for ...
Posted by Michael Wonder on 14 Apr 2016
U.S. FDA accepts for priority review Bristol-Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) for the treatment of classical Hodgkin's lymphoma patients
14 April 2016 - Bristol-Myers Squibb Company announced today that the U.S. FDA accepted a supplemental biologics license application which seeks ...
Posted by Michael Wonder on 13 Apr 2016
Seamless oncology drug development
13 April 2016 - For more than half a century, the clinical development of anti-cancer drugs has followed a predictable and ...
Posted by Michael Wonder on 13 Apr 2016
FDA advisors vote against Clovis' rociletinib
12 April 2016 - It looks likely that Clovis Oncology’s non-small cell lung cancer drug rociletinib will hit a major setback ...
Posted by Michael Wonder on 13 Apr 2016
US approval for IDT brain cancer drug
13 April 2016 - Australian pharmaceutical company IDT’s shares have jumped almost 30 per cent on news of US approval for ...
Posted by Michael Wonder on 13 Apr 2016
FDA accepts supplemental biologics license application for Keytruda (pembrolizumab) in recurrent or metastatic head and neck cancer, and grants priority review
13 April 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) ...
Posted by Michael Wonder on 11 Apr 2016
FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
11 April 2016 - The U.S. FDA today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) ...
Posted by Michael Wonder on 11 Apr 2016
FDA grants priority review for Roche’s cancer immunotherapy atezolizumab in specific type of lung cancer
11 April 2016 - Roche today announced that the U.S. FDA has accepted the company’s Biologics License Application (BLA) and granted ...
Posted by Michael Wonder on 15 Mar 2016
FDA grants Roche’s cancer immunotherapy atezolizumab priority review for advanced bladder cancer
15 March 2016 - Roche Group today announced that the U.S. FDA has accepted the company’s biologics license application and granted ...
Posted by Michael Wonder on 11 Mar 2016
Genmab announces submission of supplemental biologics license application to FDA for ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL
10 March 2016 - The application was submitted by Novartis under the ofatumumab collaboration between Novartis and Genmab. ...
Posted by Michael Wonder on 11 Mar 2016
FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer
11 March 2016 - The U.S. FDA today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer ...