FDA Alerts

The FDA approved the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.

The FDA approved the new round of vaccines for those 12 and older and authorized emergency use for children 6 months to 11 years of age.

The FDA approval follows a single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases.

Following a multicenter clinical trial, a new treatment for pneumonia caused by Acinetobacter baumannii-calcoaceticus has been approved for use in adults.

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.