The U.S. Food and Drug Administration said on Wednesday that it has approved Jazz Pharmaceuticals' drug to treat diffuse ...

The U.S. Food and Drug Administration announced Thursday it is launching "FDA PreCheck" in order to help construct drug manufacturing sites in the United States.

A drug already FDA-approved for asthma was found to nearly eliminate life-threatening allergic reactions to food allergens in ...

The U.S. Food and Drug Administration on Tuesday approved Ajovy, an injection made by Israeli drugmaker Teva Pharma, to help ...

Join our comprehensive FDA regulatory course to navigate submissions for INDs, NDAs, ANDAs, and 505(b)(2). Gain insights into FDA processes, recent changes, and strategic needs, featuring expert-led ...

A year ago, applications for a cell-cultured foie gras product were dropped off at the United States Food and Drug ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German ...

Kedrion Biopharma is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation ...

Despite concerns about increased stimulant prescribing, nonmedical use of ADHD drugs among adolescents has declined in the ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.

The administration said it is fast-tracking clinical trials that would allow patients struggling with serious mental health ...

Regeneron said on Friday the U.S. Food and Drug Administration has once again declined to approve its blood cancer therapy, this time in relation to observations from the regulator's inspection at a ...