News

STAT1h
FDA will ask outside experts to review Capricor’s therapy for Duchenne muscular dystrophy
From STAT’s Adam Feuerstein: The FDA informed Capricor Therapeutics that a meeting of outside experts will be convened to ...
Tomatoes recalled in 14 states due to salmonella risk, FDA says
Two brands of tomatoes have been recalled in 14 states due to possible salmonella contamination, the Food and Drug ...
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
STAT1h
Pharmalittle: We’re reading about FDA rehiring PDUFA staff, pharma and Medicaid prices, and more
The FDA is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers ...
BioSpace2h
FDA Rehires User Fee Negotiators After Mass Employee Layoffs: Reuters
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent ...
Exclusive-US FDA Asks Some Fired Pharma User Fee Negotiation Staff to Return
Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months ...
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 ...
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 ...
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, ...
Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
Biohaven Is Now A Compelling Contrarian Play Before Troriluzole's FDA Verdict
BHVN's Troriluzole awaits pivotal FDA approval in 2025, backed by $600M funding. Explore its diverse pipeline and promising ...
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 ...