Aurinia Sinks After FDA Official Questions Its Drug in Post

Aurinia Pharmaceuticals Inc. slumped Monday after a top Food and Drug Administration official wrote and then deleted a post ...
MedTech Dive

FDA seeks feedback on monitoring real-world performance of AI devices

The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
STAT

Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging

It’s the question biotech investors were wagging about all Monday after Tidmarsh used his personal LinkedIn page to raise ...

FDA commissioner questions need for hepatitis B shot for newborns

FDA Commissioner Dr. Marty Makary suggested the hepatitis B vaccine may not be necessary at birth amid an upcoming meeting to study the vaccine policy.
Daily Herald

FDA questions common practice of getting covid, flu vaccines together

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
PCMag on MSN

Whoop Adds Bloodwork Uploads Amid Spat With FDA Over How 'Medical' Its Wearable Is

The Advanced Labs feature incorporates blood tests with daily data gathered by the wearable for a fuller picture of your ...
ABC 7 Chicago

False negative? FDA warns of possible issue with Curative COVID-19 test

HOUSTON, Texas -- The Food and Drug Administration is issuing a warning about Curative coronavirus tests, stating the tests carry the risk of false negative results when used on people who are ...
NC Biotech

Believer Meats completes Wilson manufacturing facility, receives FDA No Questions Letter

Believer Meats recently completed the first part of its regulatory requirements, receiving a No Questions Letter from the FDA ...