New drug indication approval - September 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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). |
Healthcare professional, Industry member, Therapeutic Products
Published:
Subscribeto stay up to date with HSA news and regulatory updates.
New Drug Indication Approvals