FDA Approves 46 Novel Drugs in 2025

The US Food and Drug Administration (FDA) approved 46 novel drugs in 2025, demonstrating continued innovation in pharmaceutical development despite regulatory challenges. These approvals span multiple therapeutic areas including oncology, cardiology, neurology, and rare diseases. Key highlights include: 1. **Cardamyst (etripamil)** - A calcium channel blocker for treating paroxysmal supraventricular tachycardia, offering patients a rapid-acting nasal spray option. 2. **Lerochol (lerodalcibep-liga)** - A novel PCSK9 inhibitor for lowering LDL cholesterol, providing an alternative treatment for patients with hypercholesterolemia. 3. **Myqorzo (aficamten)** - A cardiac myosin inhibitor approved for hypertrophic cardiomyopathy, representing a new class of heart failure medications. 4. **Anzupgo (delgocitinib)** - The first topical JAK inhibitor for chronic hand eczema, offering targeted treatment with reduced systemic exposure. 5. **Donanemab-azbt (Kisunla)** - An anti-amyloid antibody for Alzheimer's disease, showing promise in slowing cognitive decline in early-stage patients. 6. **Nalmefene injection (Zurnai)** - An opioid antagonist for emergency treatment of opioid overdose, addressing the ongoing opioid crisis. The FDA's continued approval of innovative therapies reflects the pharmaceutical industry's commitment to addressing unmet medical needs and improving patient outcomes worldwide.