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BioSpace3h
FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There's new uncertainty about updated COVID-19 shots this fall after the Trump administration's handling of a shot from ...
FDA appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...
Becker's Hospital Review9h
Feds ask for new clinical trial for Novavax COVID-19 shot
Federal regulators have requested that Novavax conduct an additional randomized clinical trial of its COVID-19 vaccine, a costly demand that could threaten the company’s ability to comply, The Wall ...
Novavax Stock Is Up Again. There Are Still Big Questions About the Fate of Its Covid Shot.
Novavax said Monday morning that the Food and Drug Administration was asking the company to run a new trial of its Covid-19 ...
BioPharma Dive15h
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...