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The head of the Butantan Institute, which is leading the trial, does not believe the adverse event is related to the vaccine, Sinovac claims. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is considering changes to how it evaluates the cost-effectiveness of medicines and is inviting public comment. Read More
Rick Bright, who was leading the vaccine effort at NIH’s Biomedical Advanced Research and Development Authority (BARDA) but was pushed aside by the Trump administration, has joined President-Elect Joe Biden’s Transition COVID-19 Advisory Board. Read More
As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process. Read More
Regulatory approval “should be based on an independent scientific assessment of the balance of benefits and risks,” the joint statement said. Read More
The FDA has published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More
Biogen and the FDA failed to convince an advisory committee in a crucial meeting Friday that the company’s potential blockbuster Alzheimer’s drug aducanumab has shown enough evidence of effectiveness. Read More
Although specialty drugs make up only a small fraction of the total retail prescriptions filled in the U.S., they accounted for 37.7 percent of retail and mail-order prescription net spending from 2016 to 2017 even with rebates factored in, a new analysis has found. Read More