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Infectious Disease

Infectious Disease: A New Era of Antimicrobial Innovation Amid Global Threats

Infectious diseases remain a leading cause of global morbidity and mortality. The rise of drug- resistant pathogens, emerging viruses, and pandemics has driven rapid innovation in antimicrobial development—culminating in several novel agents approved by the FDA between 2019 and 2025.

New FDA-Approved Agents (2019–2025)

 

YearAgentCompanyIndication / Novelty
2019PretomanidTB AllianceXDR/MDR TB – first-in-class nitroimidazole for drug-resistant TB (fda.gov)
2019Lefamulin (Xenleta)NabrivaOral/IV antibiotic for CABP; first systemic pleuromutilin
2019LefamulinIncluded above
2019Cefiderocol (Fetroja)ShionogiCarbapenem-resistant Gram-negative cUTI
2019Recarbrio (imipenem/cilastatin/relebactam)MerckResistant Gram-negative infections
2020Remdesivir (Veklury)GileadHospitalized COVID-19
2021Ibrexafungerp (Brexafemme)ScynexisFirst oral triterpenoid antifungal for VVC
2021Apretude (cabotegravir)ViiVLong-acting HIV PrEP injection
2021FexinidazoleSanofi/DNDiFirst all-oral sleeping sickness therapy
2023Rezafungin (Rezzayo)Cidara/MelintaOnce-weekly echinocandin for candidemia
2023Sulbactam–durlobactam (Xacduro)EntasisResistant A. baumannii pneumonia
2023Paxlovid (nirmatrelvir/ritonavir)PfizerOral COVID-19 antiviral
2024Ceftobiprole (Zevtera)BasileaSAB, ABSSSI, CABP
2024Pivmecillinam (Pivya)FDA-initiatedUncomplicated UTI in women
2025Emblaveo (aztreonam/avibactam)AbbVie/PfizercIAI with resistant pathogens
2025Yeztugo (lenacapavir)GileadBiannual injectable HIV PrEP; capsid inhibitor
2025Clesrovimab (Enflonsia)MerckProphylaxis for RSV in infants via monoclonal antibody

Emerging Therapeutic Strategies

  • ●  Long-acting injectables: Cabotegravir and lenacapavir make disease prevention more convenient and adherence-friendly.
  • ●  New antifungal agents: Ibrexafungerp and rezafungin combat resistant fungal strains.
  • ●  Monoclonals for prevention: Clesrovimab offers passive RSV immunity in vulnerable infants.
  • ●  Resistance-focused antibiotics: Emblaveo and cefiderocol tackle hard-to-treat Gram- negative infections.
  • ●  Global health breakthroughs: Pretomanid and fexinidazole provide essential tools in the fight against neglected tropical diseases.
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Diagnostics & Stewardship

Precision antimicrobials demand precise diagnostics:

  • ●  Rapid molecular tests and resistance gene panels enable targeted therapy.
  • ●  Stewardship programs in hospitals guide appropriate use, minimizing resistance emergence.
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Future Directions

The infectious disease training landscape is evolving:

  • ●  Pan-viral agents ready for future outbreaks
  • ●  Phage therapy to target resistant microorganisms
  • ●  RNA-based therapies and vaccines fueled by mRNA technology acceleration
  • ●  Global access initiatives, especially for underserved regions and neglected diseases

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