FDA Alerts

Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The FDA has approved empagliflozin, and empagliflozin and hydrochloride to help manage type 2 diabetes in pediatric patients.

The FDA has approved a new buprenorphine treatment option for people with opioid use disorder following clinical trials that tested its safety and efficacy.

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...