US FDA tests faster follow-up process for drug reviews

The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
STAT

FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk

Risk of “acute, serious, and life-threatening” heart inflammation is now on the label of Sarepta's gene therapy for Duchenne ...
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 ...

FDA’s Plan to Speed Drug Reviews Risks Skepticism From Insurers

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...
Parkersburg News and Sentinel

FDA panel is split on updates to COVID shots as questions loom for fall vaccinations

Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at ...
JD Supra

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...
JD Supra

FDA’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...
FierceBiotech

UPDATE: Analyst questions impact of FDA's rare disease pathway proposal

The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...
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 ...