FDA Novel Drug Approvals – January 2025

Feb 012025
 
Drug Name
Active Ingredient(s)
Approval Date
FDA-Approved Use on Approval Date
Press Release
Drug Trials Snapshot
Journavx suzetrigine 1/30/2025 To treat moderate to severe acute pain Press Release
Grafapex treosulfan 1/21/2025 For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
Datroway datopotamab deruxtecan-dlnk 1/17/2025 To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

FDA Novel Drug Approvals – December 2024

Jan 012025
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Alhemo concizumab-mtci 12/20/2024 For routine prophylaxis to prevent bleeding

FDA Novel Drug Approvals – November 2024

Dec 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Iomervu iomeprol 11/27/2024 For use as a radiographic contrast

FDA Novel Drug Approvals – October 2024

Nov 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Orlynvah sulopenem etzadroxil, probenecid 10/25/2024 To treat uncomplicated urinary

FDA Novel Drug Approvals – September 2024

Oct 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Flyrcado flurpiridaz F 18 9/27/2024 A radioactive diagnostic drug to evaluate

FDA Novel Drug Approvals – August 2024

Sep 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Lazcluze lazertinib 8/19/2024 To treat non-small cell lung cancer

FDA Novel Drug Approvals – July 2024

Aug 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Leqselvi deuruxolitinib 7/25/2024 To treat severe alopecia areata Kisunla

FDA Novel Drug Approvals – June 2024

Jul 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Ohtuvayre ensifentrine 6/26/2024 To treat chronic obstructive pulmonary disease Piasky

FDA Novel Drug Approvals – May 2024

Jun 032024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Imdelltra tarlatamab-dlle 5/16/2024 To treat extensive stage small cell

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