FDA Alerts

The FDA has expanded the age ranges of individuals who may receive the human papillomavirus 9-valent vaccine.

The new humanized monoclonal antibody acts by reducing the effect of CGRP, which is believed to have a physiologic role in migraine.

In an FDA statement, Scott Gotlieb, MD, discusses the pathogen added to the list of foodborne pathogens to routinely test for, why it was added, and the FDA’s ongoing efforts to screen domestic and imported...

The FDA has approved a new migraine injection available in weekly and monthly dosing options.

The FDA has approved a new dosage strength for the combination of buprenorphine and naloxone for the maintenance treatment of opioid dependence.

The FDA has approved a new injectable fluorocycline antibiotic for the treatment of complicated intraabdominal infections.

The US Food and Drug Administration has approved a shortened version of existing brain stimulation protocol for treatment-resistant major depressive disorder.

The FDA has approved the first drug for the treatment of neurotrophic keratitis, a rare disease of the cornea.

The FDA has approved a new drug for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.

The FDA has approved the first generic version of EpiPen and EpiPen Jr auto-injector for the treatment of allergic reactions, including anaphylaxis, in adults and children over 33 pounds.