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RSS FeedPosted by Michael Wonder on 11 Dec 2016
Cardiorentis’ ularitide receives FDA fast track designation for the treatment of acute decompensated heart failure
11 December 2015 - TRUE-AHF phase III top line results anticipated in spring 2016. ...
Posted by Michael Wonder on 11 Dec 2016
ARCA Biopharma receives FDA fast track designation for Gencaro atrial fibrillation development in a genetically targeted heart failure population
13 April 2015 - ARCA Biopharma today announced that the U.S. FDA has designated as a fast track development program the ...
Posted by Michael Wonder on 10 Dec 2016
Big price hikes seen in drug that prevents overdose deaths
9 December 2016 - Two of the largest suppliers of the life-saving drug naloxone have dramatically increased their prices in ...
Posted by Michael Wonder on 10 Dec 2016
New diabetes guidelines imminent, Jardiance sales may surge
9 December 2016 - Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment ...
Posted by Michael Wonder on 09 Dec 2016
US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
9 December 2016 - FDA grants priority review status with PDUFA set for Q2 2017. ...
Posted by Michael Wonder on 08 Dec 2016
Real world evidence — what is it and what can it tell us?
7 December 2016 - The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical ...
Posted by Michael Wonder on 08 Dec 2016
1 patient, 7 tumours and 100 billion cells equal 1 striking recovery
7 December 2016 - The remarkable recovery of a woman with advanced colon cancer, after treatment with cells from her ...
Posted by Michael Wonder on 08 Dec 2016
Trump team said to consider Thiel associate O’Neill for FDA
8 December 2016 - In speech, said FDA could approve drugs without efficacy data. ...
Posted by Michael Wonder on 08 Dec 2016
Neovacs obtains FDA “fast track” designation for IFNα kinoid in lupus (SLE)
7 December 2016 - Neovacs today announced that the U.S. FDA has granted “fast track” status to IFNα kinoid in ...
Posted by Michael Wonder on 08 Dec 2016
US Senate clears bill to ease FDA drug and device approvals
7 December 2016 - Measure includes money for NIH, cancer moonshot, precision medicine initiative. ...
Posted by Michael Wonder on 07 Dec 2016
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy for a specific type of advanced ovarian cancer
6 December 2016 - In the United States, Avastin is now approved for nine distinct uses across six different types ...
Posted by Michael Wonder on 07 Dec 2016
Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes
5 December 2016 - Novo Nordisk today announced the submission of a new drug application to the US FDA and ...
Posted by Michael Wonder on 05 Dec 2016
Merck CEO says drug maker is ‘restrained’ on price increases
1 December 2016 - CEO isn’t interested in big mergers, seeks value in the labs. ...
Posted by Michael Wonder on 02 Dec 2016
Cancer drugs may remain approved despite lack of benefit
1 December 2016 - In the United States, cancer drugs are sometimes approved through sped-up processes - and they often ...
Posted by Michael Wonder on 02 Dec 2016
Trump may be more ‘vicious’ on drug prices, pharma CEO says
1 December 2016 - Drugmakers have ‘false sense of relief’ over Trump win. ...