News

FDA Commissioner: No Major Reorganization, Just Smart Reforms
In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
Exclusive: Trump administration banned chosen names at FDA, CDC, NIH under new gender policy
Health and Human Services employees were told in March to remove 'nicknames' from email systems and signatures to comply with ...
COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
FDA Recalls Bread Across the U.S. Due to ‘Glass Fragments Found’
The FDA is recalling hundreds of cases of bread due to contamination with “glass fragments.” Here is a list of impacted ...
STAT1d
Will the FDA approve the first new drug to help people quit smoking in 20 years?
The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...
Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback
Company initiates formal regulatory engagement on trial design for Alzheimer’s, dementia, and MCI indicationsHOUSTON, TX, May ...
JD Supra1d
FDA Food Chemical Regulation After the MAHA Executive Order
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive ...
STAT2d
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
BioPharma Dive23h
J&J secures FDA OK for immune drug touted as future blockbuster
The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in ...
American Council on Science and Health5hOpinion
FDA in Crisis: How Trump Administration Downsizing Is Slowing Medical Innovation and Endangering Public Health
Recent reorganizations and "reductions in force" at the FDA have damaged the very backbone of our public health system.