New Drug Indication Approvals

New drug indication approval - November 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

31 December 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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

Drug caption

Product Name	AKLIEF CREAM 50MCG/G
Active Ingredient (Strength)	Trifarotene(50 mcg/g)
Product Registrant	GALDERMA SINGAPORE PRIVATE LIMITED
Date of Approval	10/11/2025
Indications: Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

Drug caption

Product Name	VOCABRIA FILM-COATED TABLETS 30MG, VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML, VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML
Active Ingredient (Strength)	Cabotegravir Sodium eqv Cabotegravir(30mg), Cabotegravir(200mg/ml), Cabotegravir(200 mg/ml)
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	14/11/2025
Indications: Film-coated Tablets: VOCABRIA tablets are indicated in combination with rilpivirine tablets for short term (see Dosage and Administration) treatment of human immunodeficiency virus (HIV)-1 infection in adults and adolescents at least 12 years of age and weighing at least 35 kg, who are virologically suppressed (HIV-1 RNA of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class: - oral lead-in to assess tolerability of cabotegravir prior to administration of long acting (LA) VOCABRIA injection. - oral therapy for adults and adolescents who will miss planned dosing with VOCABRIA injection. Suspension for Injection: VOCABRIA injection is indicated in combination with rilpivirine injection for treatment of HIV-1 infection in adults and adolescents at least 12 years of age and weighing at least 35 kg, who are virologically suppressed (HIV-1 RNA < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Clinical studies).

Drug caption

Product Name	KEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active Ingredient (Strength)	Pembrolizumab(25.0 mg/mL)
Product Registrant	MSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval	04/11/2025
Indications: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM). * Evaluated via Project ORBIS

Drug caption

Product Name	OZEMPIC 1MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML, OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML
Active Ingredient (Strength)	Semaglutide(1.34mg/ml), Semaglutide(1.34mg/ml)
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	06/11/2025
Indications: Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

Drug caption

Product Name	DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 MG/2ML, DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 MG/1.14ML
Active Ingredient (Strength)	Dupilumab(300 mg/2ml), Dupilumab(200mg per 1.14mL)
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	20/11/2025
Indications: DUPIXENT is indicated for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older with inadequate response to H1 antihistamine treatment and who are naive to anti-IgE therapy for CSU. * Evaluated via Access work sharing

Subscribe to stay up to date with HSA news and regulatory updates.

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.