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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 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 ...
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
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.
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.
BioSpace14h
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 ...
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 ...
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 ...
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 ...
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” ...
Updated Covid vaccines for the fall may be in jeopardy under Kennedy's new rules
If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...