FDA Alerts

The FDA’s approval of the first gene therapy to treat high-risk non-muscle-invasive bladder cancer follow a multicenter clinical trial.

Following three studies that examined its safety and efficacy, the FDA approves the first fecal microbiota product to prevent recurring Clostridioides difficle infection in patients.

The recent FDA approval of a new oral treatment for patients with amyotrophic lateral sclerosis (ALS) adds another option for individuals who are diagnosed with the non-curable disease.

To reduce the amount of tobacco-related disease and death in the United States, the FDA is proposing additional action on flavored cigarettes and cigars.

The FDA approved an intravenous infusion medication to treat symptoms of this rare genetic disease that affects the liver, spleen, lung, and brain.

The US Food and Drug Administration has approved a new treatment for pediatric patients with active psoriatic arthritis.

The US Food and Drug Administration has approved the first systemic treatment for alopecia areata following the publication of results from 2 randomized, placebo-controlled trials.

The FDA has approved the first treatment for eosinophilic esophagitis.

A new treatment option for the management of blood sugar in individuals with type 2 diabetes is approved under FDA priority review designation.

The US Food and Drug Administration has approved a new medication therapy for the treatment of metastatic and unresectable melanoma.