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FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
MedPage Today on MSN1d
FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines
The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...
Pulmonology Advisor16h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.
BioPharma Dive2d
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” ...
Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline
The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...
Mercury News2d
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 ...
WTAE-TV3d
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
"We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with ...