New drug indication approval - August 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| 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 | 15/08/2025 |
Indications:
CALQUENCE in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated MCL who are ineligible for autologous stem cell transplant (ASCT). |
| Product Name | ALDARA CREAM 5% |
| Active Ingredient (Strength) | IMIQUIMOD(5%) |
| Product Registrant | INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED |
| Date of Approval | 06/08/2025 |
Indications:
Aldara 5% cream is indicated for:
• primary treatment of confirmed superficial basal cell carcinoma with a maximum tumour diameter of 2.0 cm, where surgery is considered inappropriate [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY, and
• treatment of clinically typical, nonhyperkeratotic, and nonhypertrophic solar (actinic) keratosis on the face and scalp [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] |
| Product Name | RYBREVANT CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/7ML |
| Active Ingredient (Strength) | Amivantamab(350mg/7ml) |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 15/08/2025 |
Indications:
RYBREVANT® is indicated:
• in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. * Evaluated via Project ORBIS |
| Product Name | WEGOVY 0.25 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.68 MG/ML,
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1MG/0.5ML,
WEGOVY 1 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34 MG/ML,
WEGOVY 0.5 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34 MG/ML,
WEGOVY 1.7 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.27 MG/ML,
WEGOVY 2.4 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 3.2 MG/ML,
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.5MG/0.5ML,
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.25MG/0.5ML,
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.7MG/0.75ML,
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.4MG/0.75ML |
| Active Ingredient (Strength) | Semaglutide(0.68mg/mL),
Semaglutide(1.0mg/0.5ml),
Semaglutide(1.34mg/ml),
Semaglutide(1.34mg/mL),
Semaglutide(2.27mg/ml),
Semaglutide(3.2mg/ml),
Semaglutide(0.5mg/0.5ml),
Semaglutide(0.25mg/0.5ml),
Semaglutide(1.7mg/ 0.75ml),
Semaglutide(2.4mg/ 0.75ml) |
| Product Registrant | NOVO NORDISK PHARMA (SINGAPORE) PTE LTD |
| Date of Approval | 22/08/2025 |
Indications:
Adults
Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity
• to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight (see section 5.1). |
| Product Name | TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML,
TECENTRIQ SOLUTION FOR INJECTION 1875MG/15ML,
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML |
| Active Ingredient (Strength) | Atezolizumab(1200 mg),
Atezolizumab(1875 mg/15ml),
Atezolizumab(840mg/14ml) |
| Product Registrant | ROCHE SINGAPORE PTE. LTD. |
| Date of Approval | 20/08/2025 |
Indications:
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with NSCLC who are ineligible for platinum-based chemotherapy and who do not have EGFR or ALK genomic tumor aberrations, who have:
• locally advanced, unresectable NSCLC not amenable for definitive chemoradiotherapy, or
• metastatic NSCLC (see section 3.1.2 Clinical / Efficacy Studies). |
Healthcare professional, Industry member, Therapeutic Products
Published:
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New Drug Indication Approvals