FDA Alerts

Two randomized, double-blind studies demonstrated that a new antipsychotic treatment for adult patients with schizophrenia may lead to a meaningful reduction in symptoms.

The nasal spray is the first vaccine for the prevention of influenza that does not need to be administered by a health care provider.

In June, following a placebo-controlled trial, the FDA approved pembrolizumab with chemotherapy to treat patients with primary advanced or recurrent endometrial carcinoma.

The first nalmefene hydrochloride auto-injector is another emergency treatment tool to reverse known or suspected opioid overdose.

The nasal spray is the first FDA-approved epinephrine product for the treatment of anaphylaxis not to be administered by injection.

The first orally disintegrating birth control tablet was designed for individuals who have trouble swallowing their medication.

The FDA previously approved lisocabtagene maraleucel as a second-line treatment option for adult patients with large B-cell lymphoma in June 2022.

The FDA approved givinostat, a nonsteroidal oral medication, for treating patients 6 years of age or older with Duchenne muscular dystrophy.

The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...

The FDA approved resmetirom for the treatment of adults with metabolic dysfunction-associated steatohepatitis with moderate-to-advanced liver fibrosis.