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 ...
Fierce Pharma4d
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 ...
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.
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 ...
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 ...
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 ...
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.
RFK Jr. will order placebo testing for new vaccines, alarming health experts
The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...
BioSpace15h
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 ...
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 ...
As FDA delays Novavax' COVID vaccine approval, patients fight back
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...