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RSS FeedPosted by Michael Wonder on 06 Dec 2017
FDA grants Genentech’s Avastin full approval for most aggressive form of brain cancer
5 December 2017 - Genentech announced today that the U.S. FDA has granted full approval for Avastin (bevacizumab) for the ...
Posted by Michael Wonder on 06 Dec 2017
Ozempic (semaglutide) approved in the US
5 December 2017 - Novo Nordisk today announced that the US FDA has approved Ozempic (semaglutide injection). ...
Posted by Michael Wonder on 05 Dec 2017
The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016
5 December 2017 - The US FDA has 4 expedited programs to speed the development and review of drugs treating serious ...
Posted by Michael Wonder on 05 Dec 2017
CVS and Aetna say merger will improve your health care. Can they deliver?
4 December 2017 - When CVS Health and Aetna announced their merger on Sunday, their executives painted an image of ...
Posted by Michael Wonder on 05 Dec 2017
This company is about to flood the U.S. with cheap HIV drugs
5 December 2017 - Patents on key branded medicines to start expiring soon. ...
Posted by Michael Wonder on 05 Dec 2017
Institute for Clinical and Economic Review posts draft scoping documents for two reviews: CGRP inhibitors for migraine and update to prior review of plaque psoriasis treatments
4 December 2017 - Documents open to public comment until 22 December 2017. ...
Posted by Michael Wonder on 04 Dec 2017
Is it time for the FDA to consider a differentiated approval system?
4 December 2017 - New investigational drugs or biologic applications that are not approved by the FDA don’t often see ...
Posted by Michael Wonder on 04 Dec 2017
CVS Health to acquire Aetna for $69 billion in year's largest acquisition
4 December 2017 - U.S. drugstore chain operator CVS Health said on Sunday it had agreed to acquire U.S. health insurer ...
Posted by Michael Wonder on 04 Dec 2017
Encouraging new uses for old drugs
4 December 2017 - US FDA approval of a new drug typically coincides with a period of patent protection, during which ...
Posted by Michael Wonder on 04 Dec 2017
Finding health care prices online—how difficult is it to be an informed health care consumer?
4 December 2017 - In the US health care system many patients face high out-of-pocket expenses because they either lack insurance ...
Posted by Michael Wonder on 04 Dec 2017
Statement by FDA Commissioner on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
4 December 2017 - The agency is the first in the world to provide a comprehensive technical framework to advise manufacturers ...
Posted by Michael Wonder on 04 Dec 2017
Alnylam chief makes pricing pledges before drug is even approved
30 November 2017 - For fifteen years, John Maraganore has been the chief executive of Alnylam Pharmaceuticals, working to prove ...
Posted by Michael Wonder on 04 Dec 2017
TherapeuticsMD announces resubmission of new drug application for TX-004HR
29 November 2017 - TherapeuticsMD announced today that it has resubmitted the new drug application for TX-004HR, the company’s investigational ...
Posted by Michael Wonder on 03 Dec 2017
ArmaGen’s AGT-181 granted fast track designation for the treatment of Hurler syndrome
30 November 2017 - ArmaGen today reported that the U.S. FDA has granted fast track designation to AGT-181, a novel, ...
Posted by Michael Wonder on 02 Dec 2017
Arog Pharmaceuticals receives FDA fast track designation for crenolanib in relapsed or refractory FLT3-positive AML
1 December 2017 - Arog Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for crenolanib for ...