Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2016
FDA approves new psoriasis drug Taltz (ixekizumab)
22 March 2016 - The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. ...
Posted by Michael Wonder on 22 Mar 2016
US Food and Drug Administration and representation of older adults in clinical trials
21 March 2016 - In the November 10, 2015 issue of Journal of Clinical Oncology, the American Society of Clinical Oncology ...
Posted by Michael Wonder on 21 Mar 2016
FDA approves new treatment for inhalation anthrax
21 March 2016 - The U.S. FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate ...
Posted by Michael Wonder on 19 Mar 2016
Eagle Pharmaceuticals receives complete response letter from FDA on Kangio (bivalirudin) application
18 March 2016 - Eagle Pharmaceuticals, today announced that it has received a Complete Response Letter from the U.S. FDA for ...
Posted by Michael Wonder on 19 Mar 2016
Allergan confirms generic Abraxane patent challenge
17 March 2016 - Allergan today confirmed that it has filed an abbreviated new drug application with the U.S. FDA seeking ...
Posted by Michael Wonder on 17 Mar 2016
Bayer receives FDA approval for Kovaltry for the treatment of children and adults with haemophilia A
17 March 2016 - The U.S. FDA today approved Bayer’s Kovaltry antihemophilic factor VIII (recombinant) for the treatment of hemophilia A ...
Posted by Michael Wonder on 17 Mar 2016
Novimmune’s NI-0501 granted breakthrough therapy designation by US FDA for treatment of patients with primary haemophagocytic lymphohistiocytosis
16 March 2016 - Novimmune today announced that the US FDA has granted breakthrough therapy designation to NI-0501 for the treatment ...
Posted by Michael Wonder on 16 Mar 2016
Biomarkers and surrogate endpoints
16 March 2016 - This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common ...
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 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, ...