Nyah Phengsitthy

Vanda Pharmaceuticals Inc. sued the Food and Drug Administration on Monday over the agency’s approval of a generic drug application for a sleep medication from one of its competitors.

A federal appeals court challenge to an Arkansas law governing drug distribution for certain pharmacies will influence whether more states enact similar regulations.

Novo Nordisk became the latest pharmaceutical company to file a lawsuit against the Biden administration’s drug price negotiation program.

Drugmaker Johnson & Johnson has agreed to negotiate drug prices with Medicare for its drugs Xarelto and Stelara, the company told Bloomberg Law Monday.

The FDA appealed a judge’s decision that struck down a portion of a rule subjecting premium cigars to regulation like other tobacco products, such as e-cigarettes and hookahs.

The Food and Drug Administration moved Tuesday to bolster the nation’s blood supply by easing some requirements for establishments that collect blood and blood components, including source plasma.

Drugmaker Merck & Co. added a company subsidiary as a plaintiff in its case against the Medicare agency’s drug price negotiation program through an amended complaint filed Thursday.

(Bloomberg) -- US Food and Drug Administration Deputy Commissioner Janet Woodcock will retire next year after nearly four decades at the regulator

The FDA has yet to finalize its plan to wipe flavored cigars off store shelves, but it’s under heavy pressure from some industry groups to scrap the rule originally due by the end of the year.

Public health groups sued US regulators a second time for failing to follow through on a plan to ban menthol-flavored