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, ...
Healio3m
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, ...
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 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
(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 ...
Targeted Oncology4h
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 ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
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.