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RSS FeedPosted by Michael Wonder on 29 Jul 2017
The Trump administration still has the power to wreak havoc on Obamacare
28 July 2017 - Republicans’ latest efforts to overhaul the Affordable Care Act, Barack Obama’s health care law, failed in the ...
Posted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes. ...
Posted by Michael Wonder on 29 Jul 2017
Abilify Maintena® (aripiprazole) for extended-release injectable suspension approved by the U.S. FDA for maintenance monotherapy treatment of bipolar I disorder
28 July 2017 - New indication for Abilify Maintena is based on studies evaluating efficacy and safety in adult patients with ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 28 Jul 2017
US Senate rejects measure to partly repeal Affordable Care Act, dealing GOP leaders a major setback
28 July 2017 - Senate Republicans suffered a dramatic failure early Friday in their bid to advance a scaled-back plan ...
Posted by Michael Wonder on 28 Jul 2017
Aradigm submits new drug application to FDA for U.S. marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
27 July 2017 - Aradigm Corporation today announced it has submitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 28 Jul 2017
Eiger announces FDA fast track designation granted for pegylated interferon lambda in hepatitis delta virus infection
27 July 2017 - Eiger BioPharmaceuticals today announced that the U.S. FDA has granted fast track designation for pegylated interferon lambda ...
Posted by Michael Wonder on 27 Jul 2017
Eagle Pharmaceuticals receives complete response letter from FDA on Ryanodex for exertional heat stroke application
26 July 2017 - Eagle Pharmaceuticals announced today that it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 27 Jul 2017
FDA announces new steps to empower consumers and advance digital health care
27 July 2017 - When people think about personalised medicine, they often think of genetic testing and sequencing of the human ...
Posted by Michael Wonder on 27 Jul 2017
Priority review vouchers for tropical disease drugs simply aren’t working
25 July 2017 - A controversial program created by Congress to spur development of new drugs for neglected tropical diseases ...
Posted by Michael Wonder on 27 Jul 2017
The expanded access navigator – helping patients in need of potentially life-saving drug treatments
24 July 2017 - Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy ...
Posted by Michael Wonder on 27 Jul 2017
FDA sets inaugural meeting of first-ever patient engagement advisory committee
25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...
Posted by Michael Wonder on 27 Jul 2017
FDA approves Eisai's Fycompa (perampanel) for use as monotherapy for the treatment of partial-onset seizures
26 July 2017 - First anti-epileptic drug to apply FDA's regulatory pathway of extrapolation for monotherapy use; FDA proposed using this ...
Posted by Michael Wonder on 27 Jul 2017
Ablynx receives fast track designation from the FDA for caplacizumab for the treatment of acquired TTP
26 July 2017 - Ablynx today announced that the U.S. FDA has granted fast track designation for caplacizumab, the Company’s ...
Posted by Michael Wonder on 27 Jul 2017
Sequoia Sciences receives FDA fast track designation for vaccine for urinary tract infections caused by multidrug-resistant bacteria
26 July 2017 - Non-antibiotic treatment approach may reduce the development of antibiotic resistance and promote antibiotic stewardship. ...