FDA Alerts

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.

After clinical trials to assess the safety, efficacy, and maintenance use, the FDA has approved the first oral treatment for moderately to severely active Crohn disease.

Following two 12-week studies, the FDA has approved the first ever medication for treating agitation in patients with dementia due to Alzheimer disease.

After an ongoing study, the FDA approves the first vaccine for the highly contagious respiratory virus for us in the United States.

The FDA has approved a treatment for Friedreich ataxia after the results of randomized, placebo-controlled study indicate a strong effectiveness in treatment.

The FDA approves the overdose medication for over-the-counter use after data supports its safe use.

Following a multicenter study, the FDA has approved the first enzyme replacement therapy in the United States to treat alpha-mannosidosis.