News

COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
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 to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...
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 ...
MedPage Today on MSN1d
FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines
The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...
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” ...
FDA to tighten vaccine approval requirements: reports
The U.S. Food and Drug Administration (FDA) is planning to require all new vaccines to undergo placebo-controlled trials ...
STAT1d
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
Pulmonology Advisor21h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.
Fierce Pharma20h
As vaccine sales slip, GSK touts 'mitigation options' for potential drug tariffs
As GSK weathers the storm of sinking vaccine sales and gears up for key launches in its specialty medicines sector, the ...
Chicago Tribune2d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded ...