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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 — the nation's only traditional ...
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.
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 ...
BioSpace12h
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 ...
FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after ...
Dermatology Advisor3d
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.
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...
BioPharma Dive4d
Moderna combination flu, COVID shot delayed amid FDA scrutiny
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
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” ...