FDA Alerts

The US Food and Drug Administration has restricted the sale and distribution of a permanent contraception device after learning that not all women are adequately informed of the device’s risks prior to...

The success of the DURATION-7 trial has led the US Food and Drug Administration to approve a new adjunctive therapy to basal insulin for adults with type 2 diabetes with inadequate glycemic control.

The FDA’s Psychopharmacologic Drugs Advisory Committee recently reviewed and voted on whether to recommend lofexidine, a non-opioid drug, for the management of opioid withdrawal.

The FDA has approved a new high-capacity long-acting insulin pen for the treatment of adults with diabetes.

The US Food and Drug Administration has granted approval to the inclusion of cardiovascular safety data from the DEVOTE trial in US prescribing information for Tresiba.

The US Food and Drug Administration has approved a new method for administration of treatment for diabetic macular edema and diabetic retinopathy.

Following the success of the reSURFACE clinical program, the US Food and Drug Administration has approved a new treatment option for adults with moderate to severe plaque psoriasis.

The US Food and Drug Administration approved the drug after trials showed a lower rate of relapse in chronic inflammatory demyelinating polyneuropathy or withdrawal for any other reason.

In a new statement, the FDA shared its plan to drastically reduce the nicotine levels in combustible tobacco products as part of its ongoing public health campaign.

The FDA has approved a new option for treatment-experienced adults with HIV infection.