USA – CDER approved 50 novel drugs in 2024, record number of biosimilars

Innovation Across Medical Conditions

In 2024, we approved 50 new drugs never before approved or marketed in the U.S.,
known as “novel” drugs. We also made other important approval decisions, such as
approving previously approved drugs for new uses and broader patient populations. The 2024 actions, both novel and other important drug approvals, focus on prevention, diagnosis, and treatment of diseases and conditions such as:

• Infectious diseases and associated conditions, including COVID-19, bloodstream
infections, bacterial skin and associated tissue infections, community-acquired
bacterial pneumonia, and urinary tract infections.
• Neurological conditions, such as Alzheimer’s disease and multiple sclerosis.
• Opioid use, misuse, and abuse.
• Heart, blood, and kidney diseases, including hypertension (high blood pressure);
types of hemophilia (a blood clotting disorder); and major adverse cardiovascular
events in adults at high risk.
• Lung diseases, such as chronic obstructive pulmonary disease.
• Different types of cancer, such as biliary, bladder, blood, breast, esophageal, lung,
and low-grade gliomas (tumors that start in the brain)…