News

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 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, ...
Healio14m
FDA grants regenerative medicine advanced therapy designation to 4D-150 in DME
The FDA granted regenerative medicine advanced therapy designation to 4D-150 for the treatment of diabetic macular edema, ...
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 ...
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 ...
The FDA suspended a milk testing program. Is it safe to buy & drink in NC?
Yes. Though the FDA has suspended its proficiency testing program, milk products are still safe to consume in North Carolina. That’s because milk products are tested at the state level, Jonathan Allen ...
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 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 ...
Fierce Biotech4h
FDA frees Amgen's phase 1 obesity asset from clinical trial hold
The FDA has freed Amgen’s mysterious early-stage obesity asset from a clinical hold, with the phase 1 study now enrolling ...
Targeted Oncology5h
FDA Actions in Oncology: April 2025 Approvals and Designations
A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is 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 ...
Candy Recall Update as FDA Sets Risk Level
Milk not declared as an allergen was found in a Tennessee-based manufacturer's confectionery, not the first time candy has been recalled in the U.S. in 2025.