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RSS FeedPosted by Michael Wonder on 05 Jul 2016
Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products
30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer ...
Posted by Michael Wonder on 29 Jun 2016
Statement from FDA Commissioner announcing the acting director of the FDA Oncology Center of Excellence
29 June 2016 - The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative ...
Posted by Michael Wonder on 27 Jun 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for advanced form of bladder cancer
27 June 2016 - This milestone marks the sixth breakthrough therapy designation for Opdivo. ...
Posted by Michael Wonder on 20 Jun 2016
Ariad initiates submission of new drug application for brigatinib to the U.S. FDA ahead of plan
17 June 2016 - Ariad Pharmaceuticals today announced the initiation of a new drug application submission for its investigational anaplastic lymphoma ...
Posted by Michael Wonder on 10 Jun 2016
Regulator says too many drug makers chasing same cancer strategy
10 June 2016 - A new type of cancer drug that takes the brakes off the body's immune system has given ...
Posted by Michael Wonder on 27 May 2016
Cancer drugs are the least likely to receive FDA approval
26 May 2016 - But there’s good reason to hope that may change very soon. ...
Posted by Michael Wonder on 20 May 2016
Celator Pharmaceuticals announces Vyxeos granted breakthrough therapy designation
19 May 2016 - Celator Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to Vyxeos (also known as ...
Posted by Michael Wonder on 20 May 2016
Poliovirus therapy against cancer given ‘breakthrough’ status by FDA
17 May 2016 - FDA decision will fast-track research on breakthrough Duke brain cancer therapy. ...
Posted by Michael Wonder on 19 May 2016
FDA approves an immunotherapy drug for bladder cancer
19 May 2016 - The FDA on Wednesday approved a new immunotherapy drug from Roche to treat bladder cancer, a form ...
Posted by Michael Wonder on 18 May 2016
FDA approves new, targeted treatment for bladder cancer
18 May 2016 - Tecentriq is the first PD-L1 inhibitor approved by the FDA. ...
Posted by Michael Wonder on 18 May 2016
Opdivo (nivolumab) granted first approval of a PD-1 inhibitor in haematology for the treatment of classical Hodgkin's lymphoma patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin by the FDA
17 May 2016 - Bristol-Myers Squibb today announced the U.S. FDA has approved Opdivo (nivolumab) for the treatment of patients with ...
Posted by Michael Wonder on 16 May 2016
U.S. FDA approves additional indication for Eisai's anti-cancer agent Lenvima in combination with everolimus as treatment for advanced renal cell carcinoma
16 May 2016 - Eisai announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. FDA ...
Posted by Michael Wonder on 10 May 2016
U.S. FDA expands Imbruvica (ibrutinib) label to include overall survival data in previously untreated chronic lymphocytic leukaemia and new indication for small lymphocytic lymphoma patients
9 May 2016 - AbbVie today announced the U.S. FDA updated the Imbruvica (ibrutinib) Prescribing Information to include new data from ...
Posted by Michael Wonder on 05 May 2016
FDA grants priority review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
4 May 2016 - Eli Lilly announced today that the U.S. FDA has granted priority review for the biologics license application ...
Posted by Michael Wonder on 04 May 2016
FDA grants priority review for Amgen's supplemental biologics license application for Blincyto (blinatumomab)
3 May 2016 - Amgen today announced that the US FDA has accepted for priority review the supplemental biologics license application ...