New Drug Indication Approvals

New drug indication approval - July 2025

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Healthcare professional

Industry member

Product type

Therapeutic Products

15 August 2025

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For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

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Product Name	ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Active Ingredient (Strength)	Trastuzumab deruxtecan(100 mg/vial)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	04/07/2025
Indications: Enhertu is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who show progression after at least one prior systemic treatment and who have no satisfactory alternative treatment options. *Evaluated as part of Project Orbis

Drug caption

Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML
Active Ingredient (Strength)	Nivolumab(10mg/mL)
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	03/07/2025
Indications: Hepatocellular carcinoma (HCC) OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

Drug caption

Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML
Active Ingredient (Strength)	Nivolumab(10mg/mL)
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	18/07/2025
Indications: OPDIVO, in combination with platinum-doublet chemotherapy as neoadjuvant treatment, followed by monotherapy as adjuvant treatment, is indicated in adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Drug caption

Product Name	TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML, TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
Active Ingredient (Strength)	Guselkumab(100mg/mL), Guselkumab(100mg/ml)
Product Registrant	JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval	10/07/2025
Indications: Ulcerative colitis TREMFYA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Crohn’s disease TREMFYA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. *Evaluated via Access

Drug caption

Product Name	ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Active Ingredient (Strength)	(Powder) RSV subgroup A stabilized prefusion F protein(0.06 mg/vial),(Powder) RSV subgroup B stabilized prefusion F protein(0.06 mg/vial)
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	16/07/2025
Indications: ABRYSVO is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LTRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

Drug caption

Product Name	ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 MG/ML
Active Ingredient (Strength)	Irinotecan (anhydrous free base)(4.33 mg/mL)
Product Registrant	SERVIER (S) PTE LTD
Date of Approval	14/07/2025
Indications: ONIVYDE pegylated liposomal is indicated in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,

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