The FDA approved gepotidacin (Blujepa), an oral option for the treatment of uncomplicated urogenital gonorrhea among patients ...

The U.S. Food and Drug Administration said on Tuesday it had approved the first gene therapy for a rare and life-threatening ...

The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, ...

Flow Neuroscience announced that the FDA approved its Flow at-home brain stimulation device for treating major depressive ...

The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the ...

The FDA on Tuesday approved etuvetidigene autotemcel (Waskyra) as the first cell-based gene therapy for patients 6 months and ...

FDA approves 1st gene therapy for Wiskott-Aldrich syndrome, offering a new treatment for patients lacking matched stem cell donors.

The FDA has granted approval to a new gene therapy for a rare immune disorder, the maker of which is notably not a drug ...

The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

In November 2025, the U.S. Food and Drug Administration (FDA) issued several approvals across oncology and supportive care.

Two Republican-led states are challenging more than two decades of federal decisions that allowed mifepristone to be approved ...

The drug is from a new class of antibiotics, the first new class in decades to be approved as a treatment for gonorrhea, ...