Biotech Industry Pharmaceutical Regulation

List of 2025 FDA New Drug Approvals

In 2025, FDA granted 44 novel drug approvals。This list summarizes the landmark novel therapeutic approvals, categorized by molecular modality and therapeutic area. Drug Name (Active Ingredient) Modality Company Indication Mechanism of Action (MoA) Key Highlights Journavx (Suzetrigine) Small Molecule Vertex...