US FDA approvals reach all-time high in 2015

In 2015, the US Food and Drug Administration set a new record for the number of drugs approved in one year, with 56 drugs getting the green light from the federal agency.

Last year’s therapies, approved through the FDA’s drug and biologics divisions, included 33 specialty drugs and 23 traditional drugs, according to a report by leading US pharmacy management firm Express Scripts. The previous record number of FDA approvals was in 1996 with 53 drugs gaining clearance.

Specialty drugs to treat rare conditions, as well as complex diseases such as cancer, have accounted for the majority of FDA approvals for the past five years as drug manufacturers devote more time and money to developing specialized treatments. While the majority of drugs to gain approval in 2015 were specialty drugs, several new traditional drugs to treat heart failure present new treatment options for millions of Americans. With new treatments for heart failure and high cholesterol, as well as the first biosimilar to gain approval, 2015 was a blockbuster year for drugs to gain FDA approval.