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 ...
Confronted with Death in Texas, Kennedy Finally Spoke Up for the Measles Vaccine
As a doctor and retired Republican congressman, I urge our leaders to double down on life-saving preventive medicine.
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...
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 ...
STAT6d
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.
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
CIDRAP3hOpinion
Proposed system for vaccine approval, safety monitoring begs crucial questions
Proposed changes to the vaccine approval system deserve the same scrutiny. Press reports indicate that new vaccines will be ...
BioSpace9h
FDA Action Alert: GSK, Sanofi, Merck and More
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...
Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters
The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...
Moderna Shares Fall on Vaccine Sales Miss, Delay in FDA Review
Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...
BioPharma Dive7d
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” ...
HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the ...