Blog
RSS FeedPosted 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 accepts Amgen's supplemental biologics license application for the expanded use of Enbrel (Etanercept) to treat paediatric patients with chronic severe plaque psoriasis
10 March 2016 - Amgen today announced that the U.S. FDA has accepted for review Amgen's supplemental biologics license application for ...
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 ...
Posted by Michael Wonder on 10 Mar 2016
First generic version of Viagra approved by FDA
10 March 2016 - The Pennsylvania-based pharmaceutical company Teva will be adding the drug, sildenafil citrate, for male erectile dysfunction to ...
Posted by Michael Wonder on 08 Mar 2016
Senator criticizes FDA delays in approving generic drugs
8 March 2016 - Despite receiving an extra $1 billion in fees from the generic drug user fee program, the FDA ...
Posted by Michael Wonder on 08 Mar 2016
FDA fails to adequately track safety of expedited drugs
8 March 2016 - According to a recent US Government Accountability Office report, the Food and Drug Administration lacks complete, timely, ...
Posted by Michael Wonder on 08 Mar 2016
Immunisation policy and the importance of sustainable vaccine pricing
8 March 2016 - This Viewpoint discusses vaccine costs and policy and explains the importance of balancing these factors to provide ...
Posted by Michael Wonder on 08 Mar 2016
Medimmune receives fast track designation in the US for MEDI8852 for treatment of patients hospitalised with influenza A
7 March 2016 - AstraZeneca today announced that its global biologics research and development arm, MedImmune, has received Fast Track designation ...
Posted by Michael Wonder on 08 Mar 2016
Reducing drug waste could save billions of dollars
8 March 2016 - Given how expensive many cancer drugs are, it is alarming that the government, private insurers and patients ...
Posted by Michael Wonder on 08 Mar 2016
FDA accepts supplemental biologics license application for Keytruda (pembrolizumab) in advanced non-small cell lung cancer
8 March 2016 - The application is based on data from the Keynote-010 trial, which showed superior overall survival for ...
Posted by Michael Wonder on 06 Mar 2016
Imbruvica (ibrutinib) approved by U.S. FDA for the first-line treatment of chronic lymphocytic leukaemia
4 March 2016 - The approval is based on data from the randomized, multi-center, open-label Phase 3 Resonate-2 (PCYC-1115) trial, which ...
Posted by Michael Wonder on 06 Mar 2016
U.S. FDA approves CSL Behring’s Idevlion -- the first and only haemophilia B therapy with up to 14-day dosing intervals
4 March 2016 - Idelvion is indicated in children and adults with haemophilia B for routine prophylaxis to prevent or reduce ...
Posted by Michael Wonder on 05 Mar 2016
FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B
4 March 2016 - Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX ...
Posted by Michael Wonder on 03 Mar 2016
FDA approves new indication for Faslodex (fulvestrant)
2 March 2016 - The approval expands its use and offers additional option for women with HR+, HER2- metastatic breast ...