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RSS FeedPosted by Michael Wonder on 24 May 2017
Trump's quiet on drug pricing but his FDA isn't
24 May 2017 - Scott Gottlieb, the Trump administration's FDA commissioner, generally gets a big thumbs-up from the pharmaceutical industry. ...
Posted by Michael Wonder on 24 May 2017
Estimated 23 million would lose health insurance under Republican bill: CBO
24 May 2017 - An estimated 23 million people would lose health coverage by 2026 under Republican legislation aimed at ...
Posted by Michael Wonder on 24 May 2017
U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated hepatocellular carcinoma
24 May 2017 - Application is based on results from the Phase 1/2 CheckMate-040 trial. ...
Posted by Michael Wonder on 24 May 2017
Is the Affordable Care Act imploding?
23 May 2017 - President Trump has said on various occasions that the Affordable Care Act is imploding, exploding, or collapsing. ...
Posted by Michael Wonder on 24 May 2017
Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
Posted by Michael Wonder on 24 May 2017
Plazomicin granted FDA breakthrough therapy designation
23 May 2017 - Breakthrough therapy designation supports the potential of plazomicin as a substantial improvement over existing therapies ...
Posted by Michael Wonder on 23 May 2017
Trump budget contains little on drug prices despite tough talk
23 May 2017 - President had promised to tackle U.S. drug-pricing issues. ...
Posted by Michael Wonder on 23 May 2017
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma
23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting. ...
Posted by Michael Wonder on 23 May 2017
FDA approves first cancer treatment for any solid tumour with a specific genetic feature
23 May 2017 - The U.S. FDA today granted accelerated approval to a treatment for patients whose cancers have a ...
Posted by Michael Wonder on 23 May 2017
Trump seeks delay of ruling on health law subsidies, prolonging uncertainty
22 May 2017 - The Trump administration asked a federal appeals court on Monday to delay ruling on a lawsuit ...
Posted by Michael Wonder on 23 May 2017
New FDA pathway to accelerate development of cell therapies
22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with ...
Posted by Michael Wonder on 23 May 2017
Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients
22 May 2017 - Kevzara is now available to U.S. patients. ...
Posted by Michael Wonder on 22 May 2017
Another voice: Patients have a right to the treatments ordered by doctors
22 May 2017 - For too long, insurance-backed groups have been given enormous power to overrule doctors’ orders and make ...
Posted by Michael Wonder on 22 May 2017
A vital drug runs low, though its base ingredient is in many kitchens
21 May 2017 - Hospitals around the country are scrambling to stockpile vials of a critical drug — even postponing ...
Posted by Michael Wonder on 22 May 2017
Drugs approved with limited data aren’t always well-tested later
19 May 2017 - New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven ...