News

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 ...
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 appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...
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 ...
MedPage Today1d
FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional ...
Pulmonology Advisor12h
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 Pharma11h
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” ...
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.
STAT20h
What was big at AACR? A drug, a diagnostic, and a dog. Oh and a vaccine, too.
We’d like to introduce you to the fellow above, whose name is Jae. When asked what area of study she specializes in, she only ...
Reuters7d
As FDA delays Novavax' COVID vaccine approval, patients fight back
On Wednesday, the company got word that the FDA would consider approving the vaccine, provided Novavax agrees to produce additional clinical data on the vaccine's efficacy following its approval.