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The agent targets excessive daytime sleepiness.

Pharmacies will need to obtain pre-dispense authorization for clozapine.

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

Drugs that provide only incremental benefit may not be included on clinical pathways.

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.

The findings were similar in people with or without diabetes.

Competition among branded products did not substantially curb annual spending increases.

A substantial discount would be needed to meet cost-effectiveness thresholds.

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

Angiotensin receptor blockers may be less likely to cause side effects than ACE inhibitors.

Current drug shortages based on FDA data, prepared by Formulary Watch.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

When Medicare D plans do provide coverage for first generics, they are often placed on non-generic tiers.

The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.

The therapy is approved for both adults and children.

Azstarys is approved to treat patients 6 years and older.

Most of the suspected cases of myocarditis developed after the second dose of the vaccine and were among younger males.

The company’s stock began dropping on Tuesday with analyst expectation the FDA will issue a Complete Response Letter for tenapanor, its chronic kidney disease therapy.

Eight out of 10 covered U.S. commercial lives now have access to the H. pylori therapy.

This research sought to understand the relationship of prior medication exposure, existing health conditions, and COVID-19 outcomes using data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry.

Current drug shortages based on FDA data, prepared by Formulary Watch.

FDA staff raised safety concerns ahead of the advisory panel hearing.

Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.