In 2025, the FDA is set to approve 74 novel drugs, the highest in a decade, surpassing the previous record in 2024. Oncology continues to be a major focus, with treatments for 14 tumor types, including UGN 102 for bladder cancer and TABELECLEUCEL for EBV+ PTLD. Rare disease treatments like Sebetralstat for HAE are addressing unmet needs, while NAFITHROMYCIN (MIQNAF) marks a historic breakthrough in AMR, being the first drug in its class globally in over 30 years. Suzetrigine is offering a new mechanism for acute pain relief, the first in over two decades.

Healthark Insights’ report, Top 10 Novel Drugs of 2025, highlights novel treatments expected to be approved or launched in 2025. The report emphasizes first-time to be approved drugs across various other indications, including neurology, cardiology, and immunology therapies, signaling a transformative year ahead in healthcare.

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