FDA official plans to change vaccine approval process, claiming that Covid-19 shots caused child deaths

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...
Becker's Hospital Review

FDA floats changes to vaccine approval process: 5 notes

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

FDA intends to put its most serious warning on Covid vaccines, sources say

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

FDA official Prasad says COVID shot deaths mean stricter vaccine approval standards

Vinay Prasad, the head of the US FDA's Center for Biologics Evaluations and Research which oversees vaccines, said that future vaccine approvals will face stricter standards in light of the deaths of ...

FDA approves updated label for Unloxcyt

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...
STAT

Pharmalittle: We’re reading about FDA plans for CAR-T therapies, skinny drug labels, and much more

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...
National Law Review

FSIS Announces Updated Label Approval Guideline

On0, 2025, USDA’s Food Safety and Inspection Service (FSIS) announced the availability of updated guidelines for label ...

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus.