New Drug Indication Approvals

New drug indication approval - August 2025

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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	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).

Drug caption

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]

Drug caption

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

Drug caption

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).

Drug caption

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).

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