New Drug Indication Approvals

New drug indication approval - June 2025

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Healthcare professional

Industry member

Product type

Therapeutic Products

14 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	BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG
Active Ingredient (Strength)	Bictegravir Sodium 52.45mg eqv Bictegravir(50mg),Emtricitabine(200mg),Tenofovir Alafenamide Fumarate 28.04mg eqv Tenofovir Alafenamide(25mg)
Product Registrant	GILEAD SCIENCES SINGAPORE PTE. LTD.
Date of Approval	19/06/2025
Indications: BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg: • to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

Drug caption

Product Name	DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML
Active Ingredient (Strength)	Daratumumab(1800mg/15mL)
Product Registrant	JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval	03/06/2025
Indications: DARZALEX® SC is indicated for the treatment of patients with multiple myeloma in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.

Drug caption

Product Name	TAFINLAR HARD CAPSULE 50MG, TAFINLAR DISPERSIBLE TABLET 10MG, TAFINLAR HARD CAPSULE 75MG
Active Ingredient (Strength)	Dabrafenib Mesylate 59.25mg equivalent to dabrafenib(50mg), Dabrafenib mesylate eqv Dabrafenib(10mg), Dabrafenib Mesylate 88.88mg equivalent to dabrafenib(75mg)
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	30/06/2025
Indications: Dabrafenib in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 12 Clinical studies).

Drug caption

Product Name	MEKINIST® POWDER FOR ORAL SOLUTION 4.7 MG, MEKINIST FILM-COATED TABLETS 2MG, MEKINIST FILM-COATED TABLETS 0.5MG
Active Ingredient (Strength)	Trametinib dimethylsulfoxide 5.30 mg eqv trametinib(4.7 mg), Trametinib Dimethyl Sulfoxide 2.254mg eqv trametinib(2mg), Trametinib Dimethyl Sulfoxide 0.5635mg eqv trametinib(0.5mg)
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	30/06/2025
Indications: Trametinib in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 12 Clinical studies).

Drug caption

Product Name	BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML, BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML
Active Ingredient (Strength)	Nirsevimab(50 mg/ 0.5 mL), Nirsevimab(100 mg / 1.0 mL)
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	16/06/2025
Indications: Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

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