FDA Approves 50 New Drugs in 2024, Including Groundbreaking Treatments

In 2024, the FDA approved 50 new drugs, slightly down from 55 in 2023. Noteworthy approvals include the first-ever treatment for MASH, a serious liver disease. Madrigal Pharmaceuticals’ Rezdiffra marks a breakthrough in an area where many have failed.

The FDA also approved the first two treatments for Niemann-Pick disease type C, a rare genetic disorder. Zevra Therapeutics’ Miplyffa and IntraBio’s Aqneursa received the green light, bringing new hope to patients.

Bristol Myers Squibb’s Cobenfy introduced a novel approach to schizophrenia, becoming the first drug in decades not directly blocking dopamine. Pfizer’s Hympavzi offers a new hemophilia treatment, notable for its auto-injector pen.

Merck’s Winrevair targets pulmonary arterial hypertension’s root cause, and Amgen’s Imdelltra, a T-cell engager, is now approved for advanced small-cell lung cancer. Eli Lilly’s Kisunla expands treatment for early Alzheimer’s.

Significantly, smaller biotech companies like Allecra Therapeutics and Iovance Biotherapeutics led many approvals, highlighting their growing role in drug innovation.

Additionally, digital health company Transcarent announced plans to acquire Accolade for $621 million, aiming to enhance personalized healthcare experiences and improve outcomes.