News

Neuralink's speech restoration device gets FDA's 'breakthrough' tag
(Reuters) -Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore ...
FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the ...
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 ...
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 ...
Medpage Today on MSN15hOpinion
Inside the FDA: Low Morale and Uncertainty Plague Staff
Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...
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 ...
Food Safety News18m
FDA increases import enforcement on foods because of unapproved drugs, undeclared colors and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
Fierce Pharma14h
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 ...
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 ...
dvm3609h
FDA approves new canine otitis externa medication
Dechra Announces FDA Approval of Otiserene® (marbofloxacin, terbinafine, and dexamethasone otic suspension) the latest ...
National Law Review5h
Federal Court Strikes Down FDA Rule on LDTs
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA ...
BioPharma Dive7h
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.