Over the past 12 months, the US Food and Drug Administration (FDA) approved 35 new medicines, the second highest approval rate this decade.

Amongst the approved new drugs are two lifesaving medicines for hepatitis C, breakthroughs in personalised medication for melanoma and lung cancer and a drug for late-stage prostate cancer.

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

A new drug for Hodgkin’s lymphoma is also available, the first in 30 years, as well as the first new drug for lupus in 50 years.

A new report released today revealed that 24 of the 35 approvals occurred in the US before any other country.

FDA Commissioner of Food and Drugs Margaret Hamburg, MD, said that 35 major drug approvals in one year represented a very strong performance.

"We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century," Hamburg said.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

The FDA cites expedited approval processes and flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act as major factors behind the high approval rates.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.

Discover the Impact