FDA Actions in Brief

After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.

The FDA has approved UCB's Bimzelx for moderate-to-severe hidradenitis suppurativa, offering a new treatment option for this painful autoimmune skin disease.

A total of 17 lots are now part of the recall of Clonazepam because some cartons have the wrong strength on the label.

Relapsed or refractory acute leukemia with a KMT2A translocation currently has an overall survival rate of less than one year when treated with frontline therapies.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for reproxalap for patients with dry eye disease. Reproxalap also is being tested in allergic conjunctivitis.

Monjuvi is available under an accelerated approval to treat adults with relapsed or refractory diffuse large B-cell lymphoma.