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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 to Require Placebo-Controlled Trials for Vaccine Approvals
The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...
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 ...
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 ...
Pulmonology Advisor19h
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.
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.
Fierce Pharma18h
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 ...
BioPharma Dive2d
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” ...
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 ...
WXYZ Detroit 7, MI on MSN11h
FDA Commissioner says they're looking at whether to approve COVID vaccine for next winter
The FDA may be making changes to how it handles COVID-19 booster shots. The agency’s top official says they’re taking a closer look at whether to approve boosters for this winter.