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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 scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine is sowing uncertainty about other ...
Dermatology Advisor4d
Novavax COVID Vaccine Moves Closer to Full FDA Approval
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
FDA chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.
MedPage Today on MSN5dOpinion
Inside the FDA: Low Morale and Uncertainty Plague Staff
Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...
Moderna, Pharma Stocks Fall as FDA Names Industry Critic as Top Vaccine Regulator
Dr. Vinay Prasad succeeds Dr. Peter Marks, who left the role of leader of the FDA’s Center for Biologics Evaluation and ...
Fierce Pharma5d
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 ...
The Daily Record (Maryland)5d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss ...
BioSpace4d
FDA to Rehire Some Travel Staff as Lapses Begin to Show: AP
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as ...
CBS News6d
FDA chief says they're looking at whether to approve COVID shots for next winter
Novavax said Monday that the FDA had asked the company to commit to another clinical trial of the shot. "Today, there is broad population immunity, and the big question is does it provide a benefit?
IFLScience on MSN9h
A blanket requirement for placebo-controlled trials threatens research ethics and vaccine access, it’s being argued.
A blanket requirement for placebo-controlled trials threatens research ethics and vaccine access, it’s being argued.