KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary ...

New and Unprecedented Survival, Respiratory, and Biomarker Data Prove that NurOwn Helps People with ALS Live Longer and Live ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

Consumption of impacted products could cause "serious adverse health consequences or death," according to the FDA.

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug ...

Boston Scientific (NYSE: BSX) announced that the FDA approved an expansion to the label of its Farapulse pulsed field ...

Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the ...

In a significant development, the Maharashtra Food and Drug Administration (FDA) has directed chemists across the state to ...

Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful ...

Meijer Inc. announced a recall of thousands of cases of Frederik's Dark Chocolate Almonds on June 13 due to the possible ...

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...