FDA Approves 57 New Drugs, Sales Projections Decline

In 2024, the FDA approved 50 novel drugs containing new active substances, slightly down from 55 in 2023, while the European Medicines Agency (EMA) authorized 46, marking an increase from 39 the previous year. The FDA's focus included over half of its approvals for treatments targeting rare diseases, and it highlighted a significant approval for Pfizer's Hympavzi for severe hemophilia. The EMA recommended a total of 114 medicines for approval, the highest in 15 years, which included groundbreaking treatments for early Alzheimer's disease and a needle-free adrenaline option for allergic reactions. Both agencies are aligning on the urgency to address public health needs and innovation in their approvals. The EMA also endorsed several new vaccines, including one for Chikungunya and a novel mRNA vaccine for RSV. Overall, the competition between the FDA and EMA reflects a robust pipeline of innovative therapies aimed at diverse health challenges in the coming years.