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The European Commission has approved Trodelvy for first-line treatment of unresectable or metastatic triple-negative breast cancer, offering a new therapeutic option for patients with one of the most aggressive forms of breast cancer.
The Central Drugs Standard Control Organisation (CDSCO) has clarified the regulatory framework for formulation intermediates, specifying which products require central approval under the NDCT Rules, 2019 and which can be licensed by State Licensing Authorities (SLAs).
Merck Partners with Versant Ventures to Launch Saturnus Bio
Merck has partnered with Versant Ventures to establish Saturnus Bio, advancing precision medicine through gene modulation technologies for rare genetic cardiomyopathies.
EU Approves Sanofi's Cenrifki (Tolebrutinib) for Multiple Sclerosis
The European Commission (EC) has approved Sanofi’s Cenrifki (tolebrutinib) as the first disability-targeting treatment for adults with Secondary Progressive Multiple Sclerosis (SPMS) without relapses.
US FDA and EMA Accept Cemdisiran Regulatory Submissions for Generalised Myasthenia Gravis
The FDA and EMA have accepted regulatory submissions for cemdisiran to treat generalised Myasthenia Gravis (gMG). If approved, it could become the first siRNA therapy for gMG with convenient quarterly subcutaneous dosing.
EU Approves Chiesi's LOJUXTA for Pediatric HoFH Patients
The European Commission has approved Chiesi’s LOJUXTA (lomitapide) for children aged 5 years and older with Homozygous Familial Hypercholesterolaemia (HoFH), expanding treatment options for this ultra-rare genetic disorder.
IPC Conducts 2nd Training on EG and DEG Testing in Oral Liquid Medicines
IPC successfully conducted its second hands-on training on Ethylene Glycol (EG) and diethylene glycol (DEG) determination in oral liquid preparations by gas chromatography, strengthening analytical capabilities and drug quality monitoring in regulatory laboratories.
DoP Seeks Stakeholder Feedback on GTE Medical Device Exemption Amendments
The Department of Pharmaceuticals (DoP) has invited stakeholder comments on proposed amendments to the Global Tender Enquiry (GTE) exemption list for medical devices. Feedback can be submitted until July 15, 2026.
Japan Approves Sanofi's Wayrilz for Immune Thrombocytopenia
Sanofi’s Wayrilz has been approved in Japan for the treatment of immune thrombocytopenia (ITP). The BTK inhibitor works through multi-immune modulation to address the underlying causes of the disease.
European Commission Approves AbbVie's MAVIRET for Acute Hepatitis C
The European Commission (EC) has approved AbbVie’s MAVIRET for acute Hepatitis C Virus (HCV) infection, enabling earlier treatment initiation to help reduce disease progression, cirrhosis, and liver cancer risk.
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