News

RFK Jr.’s new vaccine testing rule agitates industry, experts
When the Department of Health and Human Services (HHS) announced a new requirement for placebo testing on all new vaccines ...
STAT4dOpinion
A court decision on lab-developed tests sets a dangerous precedent
An under-the-radar court ruling may be among the most significant harbingers of the crises to come for the FDA and public ...
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 ...
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 ...
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 ...
CNN14d
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 vaccine as a post-approval commitment, a source familiar with the ...
Pharmabiz14d
US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test
Pierre Arsène, founder and CEO of Mursla Bio, said: “This designation is a powerful validation of both our scientific vision and clinical strategy – EvoLiver is the first liver cancer surveillance ...
The Greenville News15d
FDA suspends dairy quality testing amid federal workforce cuts. Is it safe to consume milk?
The FDA temporarily suspended some milk quality tests due to federal workforce cuts. Testing of Grade A dairy products like milk, cheese, and yogurt has been paused. Experts say consumers should ...