Medical Device and Diagnostic Industry (MD+DI)Opinion

FDA's Deregulation of Wellness Devices Is a Slippery Slope

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
Hosted on MSN

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 ...
MPR

FDA Cites Trial Concerns in Rejection of Tabelecleucel for EBV+ PTLD

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
Fierce Biotech

FDA cites severe liver injury risk, unclear benefit behind Sanofi's MS drug rejection

Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...
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 ...
UUHC Health Feed

Common Questions About the FDA-Approved Alzheimer’s Blood Test

Alzheimer’s disease is a devastating condition that affects more than 7 million Americans, according to the Alzheimer’s Association. As the Baby Boomer generation ages, this number is estimated to ...
JD Supra

FDA’s Release of Complete Response Letters Raises Questions Related to Intellectual Property

In an unprecedented move, starting in July 2025, the U.S. Food and Drug Administration (FDA) released communications that have previously remained unpublished and confidential to the public.