The Drug Update: Recent drug approvals, summer 2025 edition

Area of Science:

• Pharmacology and Therapeutics
• Drug Approval and Regulation
• Primary Care Medicine

Background:

• The US Food and Drug Administration (FDA) plays a crucial role in approving new medications.
• Primary care physicians require timely updates on newly approved drugs and indications.
• Late 2024 saw significant FDA approvals impacting various therapeutic areas.

Purpose of the Study:

• To summarize key FDA drug approvals relevant to primary care practice in the latter half of 2024.
• To highlight novel therapeutic agents and expanded indications for existing drugs.
• To provide a concise overview for healthcare professionals.

Main Methods:

• Review of FDA approval announcements and press releases.
• Identification of drugs approved between July and December 2024.
• Focus on medications with direct or potential primary care applications.
• Inclusion of new indications for previously approved drugs.

Main Results:

• Approval of donanemab-azbt (Kisunla) for Alzheimer's disease.
• Approval of nalmefene injection (Zurnai) for opioid overdose.
• Approval of epinephrine nasal spray (neffy) for allergic reactions.
• Approval of palopegteriparatide (Yorvipath) for osteoporosis.
• Approval of xanomeline and trospium chloride (Cobenfy) for schizophrenia.
• Approval of sulopenem etzadroxil/probenecid (Orlynvah) for urinary tract infections.
• New indication for tirzepatide (Zepbound) in obstructive sleep apnea.
• New indication for dupilumab (Dupixent) in chronic obstructive pulmonary disease.

Conclusions:

• The latter half of 2024 introduced several important new drugs and indications for primary care.
• These approvals offer new treatment options for conditions ranging from neurological disorders to respiratory diseases.
• Staying abreast of these regulatory decisions is vital for evidence-based primary care practice.