News

FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, ...
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 ...
Neuralink's speech restoration device gets FDA's 'breakthrough' tag
Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...
Ask a health professional: What does the FDA’s food dye phase-out mean for families?
New FDA regulations are changing what’s allowed in popular snacks and cereals. Here’s what families should know about ...
Burger Recall Update as FDA Sets Highest Risk Level
A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...
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 ...
BioPharma Dive6m
Moderna combination flu, COVID shot delayed amid FDA scrutiny
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
Becker's Hospital Review18m
FDA probes compounding pharmacies over quality concerns
The FDA plans to gather information from 250 compounding outsourcing pharmacies amid safety and quality concerns. In a May 1 notice, the agency said it will survey outsourcing facilities about ...
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 ...
Fierce Pharma7h
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
BioSpace8h
FDA Misses Another Deadline Amid Staff Exodus, Structural Disruptions
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...