New Drug Indication Approvals

New drug indication approval - September 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

14 October 2025

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

Drug caption

Product Name	SKYRIZI CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/10ML, SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 360MG/2.4ML
Active Ingredient (Strength)	Risankizumab(600mg/10mL), Risankizumab(360mg/2.4 mL)
Product Registrant	ABBVIE PTE. LTD.
Date of Approval	10/09/2025
Indications: SKYRIZI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy.

Drug caption

Product Name	MAXIGESIC IV SOLUTION FOR INFUSION 1000MG/300MG PER 100ML VIAL
Active Ingredient (Strength)	Ibuprofen sodium dihydrate eqv ibuprofen(300mg),Paracetamol(1000mg/100ml)
Product Registrant	APEX PHARMA MARKETING PTE. LTD.
Date of Approval	29/09/2025
Indications: Maxigesic® IV is indicated in adults for the relief of moderate pain and the reduction of fever, where an intravenous route of administration is considered clinically necessary. Maxigesic® IV is indicated in adults for the management of moderate to severe pain as an adjunct to opioid analgesics.

Drug caption

Product Name	CALQUENCE HARD CAPSULES 100MG, CALQUENCE FILM-COATED TABLET 100MG
Active Ingredient (Strength)	Acalabrutinib(100mg), Acalabrutinib maleate eqv acalabrutinib(100mg)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	16/09/2025
Indications: Calquence is indicated: · in combination with venetoclax with or without obinutuzumab for the treatment of patients with previously untreated CLL/SLL.

Drug caption

Product Name	IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
Active Ingredient (Strength)	Durvalumab(50 mg/ml)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	19/09/2025
Indications: Small Cell Lung Cancer (SCLC) IMFINZI is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Urothelial Carcinoma IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of patients with resectable muscle invasive bladder cancer (MIBC). * Evaluated via 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	10/09/2025
Indications: Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer. * Evaluated via Project ORBIS

Drug caption

Product Name	HIBRUKA TABLET 50MG
Active Ingredient (Strength)	Orelabrutinib(50 mg)
Product Registrant	FORTREA SINGAPORE PTE. LTD.
Date of Approval	03/09/2025
Indications: HIBRUKA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy (see 15. Clinical Trials).

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