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Novavax swings to profit, says talks with FDA on COVID vaccine approval ongoing
Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...
The FDA names a new vaccine chief with an unsettling record, joining a controversial team
Dr. Vinay Prasad, the FDA's new vaccine chief, has been accused of spreading misinformation about Covid vaccines.
RFK Jr. takes aim at COVID shots for kids, worrying vaccine experts
Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...
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 ...
Fewer than half of Americans trust FDA, CDC to do their job
Five years after the onset of the COVID-19 pandemic, 42 percent of people in the U.S. think federal health agencies are ...
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 ...
CIDRAP2dOpinion
Proposed system for vaccine approval, safety monitoring begs crucial questions
Proposed changes to the vaccine approval system deserve the same scrutiny. Press reports indicate that new vaccines will be ...
BioSpace3d
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 ...