The U.S. Food and Drug Administration (FDA) granted approval to Padcev on December 18, 2019, for the treatment of adults with locally advanced or metastatic urothelial cancer, a common type of bladder cancer.

The U.S. Food and Drug Administration (FDA) approved golodirsen on December 12, 2019, for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

The U.S. Food and Drug Administration (FDA) approved voxelotor on November 25, 2019, for the treatment of sickle cell disease in adults and children aged 12 years and older.

The U.S. Food and Drug Administration (FDA) approved cenobamate on November 21, 2019, for the treatment of partial-onset seizures in adults.

The U.S. Food and Drug Administration (FDA) approved Givosiran on November 20, 2019, for the treatment of acute hepatic porphyria (AHP) in adults.

The U.S. Food and Drug Administration (FDA) approved Crizanlizumab on November 15, 2019.

The U.S. Food and Drug Administration (FDA) approved Zanubrutinib on November 14, 2019.

The U.S. Food and Drug Administration (FDA) approved Cefiderocol on November 14, 2019, for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP).

The U.S. Food and Drug Administration (FDA) approved Reblozyl on November 8, 2019, for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

The U.S. Food and Drug Administration (FDA) approved diroximel fumarate, marketed under the brand name Vumerity, on October 29, 2019.

Trikafta, a combination of elexacaftor, ivacaftor, and tezacaftor, was approved by the U.S. Food and Drug Administration (FDA) on October 21, 2019.

The FDA granted approval for lasmiditan on October 11, 2019. This approval marked the introduction of lasmiditan as a novel treatment option for the acute management of migraine attacks in adults, with or without aura.