FDA Alerts

The FDA has examined the results of a recent confirmatory trial to verify the clinical benefit of an amyloid beta-directed antibody for the treatment of Alzheimer disease.

Following two trials, the FDA has approved the first treatment for molluscum contagiosum.

Following three clinical trials, the FDA has approved a new preventive treatment for neonates, infants, and toddlers that prevents respiratory syncytial virus (RSV) in those age populations.

The FDA has approved the first daily oral contraceptive for the prevention of pregnancy that does not require a health care provider’s prescription.

Following two studies, the FDA has approved the first cellular therapy for the treatment of type 1 diabetes in patients.

The FDA approved the first treatment for pediatric patients who experience functional constipation

This FDA Roundup includes an at-a-glance look at the latest FDA drug approvals in April and May, including treatment for menopausal hot flashes, Clostridioides difficile infection, suspected opioid...

The US FDA recently approved a novel treatment for moderate to severe vasomotor symptoms that are caused by menopause.

The FDA has approved the first orally administered treatment for the gut infection—clostridioides difficile.

The FDA’s approval of nalmefene hydrochloride nasal spray marks the first of its kind for health care and community use.