FDA Alerts

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

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

A generic drug-product combination for the treatment of asthma and COPD was just approved by the US Food and Drug Administration.

The US Food and Drug Administration has approved a treatment option for adults with heart failure.

The US Food and Drug Administration has approved a second vaccine for the prevention of COVID-19.

The US Food and Drug Administration has approved the drug based on the results from the KEEPsAKE-1 and KEEPsAKE-2 randomized, placebo-controlled studies.

The drug is approved as a diagnostic tool to help identify cancerous lesions during surgery, which is normally difficult to detect. The drug is administered intravenously prior to surgery.

The medication is indicated for adults and children aged 12 years or older weighing at least 35 kg, and few adverse effects were reported in clinical trials.

It is the first and only cell-based quadrivalent influenza vaccine in the United States and is an alternative for individuals allergic to the egg-based vaccines.