Incyte INCY announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and "unleash AI." ...

The vaccine is expected to be available this fall. The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to 64 years at high ...

The US Food and Drug Administration has approved Moderna’s next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the ...

The U.S. Food and Drug Administration approved Novavax’s Covid-19 vaccine, but limited its use to older adults and people over the age of 12 with conditions that put them at risk due to the ...

That change will be discussed at a meeting of FDA vaccine advisers later this week. The approval restricts the ... Control and Prevention, a wide list of conditions constitutes an additional ...

The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based ...

WILMINGTON, Del., May 15, 2025--FDA Approves Zynyz (retifanlimab-dlwr) the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States ...

The FDA approved the VENTANA MET (SP44) RxDx assay as a companion diagnostic to identify c-Met protein expression in non-squamous NSCLC patients eligible for treatment with Emrelis.

The U.S. Food & Drug Administration (FDA) has announced the approval of three natural-source colors in food items. Galdieria extract blue, butterfly pea flower extract and calcium phosphate can ...

The FDA approved three natural food dyes this week amid its transition away from petroleum-based dyes in the food supply. The colors "will expand the palette of available colors from natural ...