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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 Advisor17h
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 ...
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 ...
Monthly Prescribing Reference3d
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Full approval from the FDA means a product can stay on the market even after a health emergency ends. HealthDay News — Novavax’s COVID-19 vaccine could soon receive full approval from the US ...
Seeking Alpha5d
Novavax told by FDA to conduct additional study for COVID vaccine - report
The U.S. FDA is asking Novavax (NASDAQ:NVAX) to conduct an additional randomized, controlled study of its COVID-19 vaccine before it will consider approving it. The prospect is a major setback for ...