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RSS FeedPosted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 21 Apr 2018
U.S. FDA grants fast track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin as third-line therapy for metastatic breast cancer
19 April 2018 - Polyphor announced today that the U.S. FDA has granted fast track designation for its novel immuno-oncology candidate ...
Posted by Michael Wonder on 21 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of Akynzeo (fosnetupitant/palonosetron) in the United States
20 April 2018 - Helsinn today announces that the U.S. FDA has approved the intravenous formulation of Akynzeo (NEPA, a ...
Posted by Michael Wonder on 21 Apr 2018
FDA commissioner to drug middlemen: you're part of the problem
19 April 2018 - The FDA has approved nine biosimilars, generic versions of biologic medicines, but only three are available in ...
Posted by Michael Wonder on 19 Apr 2018
FDA staff raises safety concerns over Lilly/Incyte arthritis drug
19 April 2018 - An experimental rheumatoid arthritis drug developed by Eli Lilly and Incyte poses serious risks of deadly blood ...
Posted by Michael Wonder on 19 Apr 2018
Price tag for newly approved Crysvita is "responsible," says PBM Express Scripts
18 April 2018 - Taking the rebates that it expects to negotiate into consideration, Ultragenyx said that burosumab will cost approximately ...
Posted by Michael Wonder on 19 Apr 2018
US FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer
18 April 2018 - Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard ...
Posted by Michael Wonder on 18 Apr 2018
Calithera Biosciences announces FDA fast track designation granted to CB-839 in combination with cabozantinib for treatment of patients with advanced renal cell carcinoma
18 April 2018 - Randomised CANTATA trial open for enrolment. ...
Posted by Michael Wonder on 18 Apr 2018
FDA official insists U.S. is catching up to Europe on biosimilar regulations, approvals
17 April 2018 - The FDA lags behind its European counterpart when it comes to approving biosimilars — but a ...
Posted by Michael Wonder on 18 Apr 2018
U.S. FDA accepts supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with small cell lung cancer and grants priority review
18 April 2018 - Bristol-Myers Squibb today announced that the U.S. FDA has accepted for priority review its supplemental biologics ...
Posted by Michael Wonder on 18 Apr 2018
Post-marketing modifications of drug labels for cancer drugs approved by the US FDA between 2006 and 2016 with and without supporting randomized controlled trials
11 April 2018 - Modifications in cancer drug indications, dosing, and related toxicities after FDA approval are common. It is unclear ...
Posted by Michael Wonder on 18 Apr 2018
FDA provides full approval to Praxbind, specific reversal agent for Pradaxa
17 April 2018 - Decision converts Praxbind’s (idarucizumab) accelerated approval, granted in October 2015, to full approval. ...
Posted by Michael Wonder on 17 Apr 2018
FDA approves Vonvendi [von Willebrand factor (recombinant)] for peri-operative management of bleeding in adult patients with von Willebrand disease
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on ...
Posted by Michael Wonder on 17 Apr 2018
Remarks from FDA Commissioner Scott Gottlieb on fiscal year 2019 budget request for FDA
17 April 2018 - As prepared for delivery to U.S. House Subcommittee on Agriculture, Rural Development. ...
Posted by Michael Wonder on 17 Apr 2018
FDA medical device safety action plan now available
17 April 2018 - FDA's vision to protect patients and promote public health. ...