News

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 ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
Medscape3h
FDA Approves First One-Time Topical Treatment for Recessive Dystrophic Epidermolysis Bullosa Wounds
In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...
STAT2h
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
DOGE Fired Drug Testing Experts. The FDA Needs Volunteers to Finish Their Work
Cutting staff is quick way to lower your costs, but a haphazard approach like DOGE's could cost your company if you ...
HealthDay on MSN8m
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic ...
Crain's Cleveland Business4h
Cleveland company receives FDA approval for rare disease treatment
Cleveland-based Abeona Therapeutics Inc. (Nasdaq: ABEO) announced Tuesday, April 29, that it has received U.S. Food and Drug ...
Arizona Daily Sun11h
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
CURE1h
An AI-Driven Companion Diagnostic Receives FDA Designation in NSCLC
The Ventana TROP2 RxDx Device, a computational companion diagnostic, was granted breakthrough device designation by the FDA ...
FDA announces voluntary recall of Trader Joe's sesame miso salad with salmon in multiple states, including Pa.
The FDA announced Monday that limited quantities of the product was voluntarily recalled because the topping packet may ...
Opinion
Cuts to the FDA are slowing medical innovation and endangering public health
If the goal of these cuts was to make the government leaner, the result has been to make it weaker. And in the realm of public health, weakness can be deadly.