The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months ...

A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...

The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

Previous policy allowed up to a 12-month delay before articles were required to be made available to the public for free ...

(Reuters) -Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore ...

Bread and rolls sold in six states have been recalled over 'glass fragments,' according to the U.S. Food and Drug ...

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

Milk not declared as an allergen was found in a Tennessee-based manufacturer's confectionery, not the first time candy has ...