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 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 scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional ...
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 MSN3d
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 ...
RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials
A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
FDA to tighten vaccine approval requirements: reports
The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.
Fierce Pharma1d
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
STAT3d
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.
Dermatology Advisor8h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
Fierce Pharma2d
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 ...