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CHMP Recommends Lilly's Jaypirca for CLL Treatment in EU
CHMP has recommended Lilly’s Jaypirca (pirtobrutinib) for EU approval in adults with chronic lymphocytic leukemia (CLL), potentially expanding its use across all lines of therapy.
Regulation | 29/06/2026 | By News Bureau
US FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each with Trodelvy
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with Trodelvy as first-line treatment for adults with PD-L1-positive (CPS ≥10) advanced Triple-Negative Breast Cancer (TNBC).
Regulation | 26/06/2026 | By News Bureau | 187
The Union Health Ministry has expanded its QR code-based drug traceability framework to include vaccines, antimicrobials, NDPS medicines, and anti-cancer drugs, strengthening authentication and supply chain transparency.
Regulation | 25/06/2026 | By News Bureau
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).
Regulation | 25/06/2026 | By News Bureau
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.
Regulation | 25/06/2026 | By News Bureau | 112
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.
Regulation | 25/06/2026 | By News Bureau | 134
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.
Regulation | 25/06/2026 | By News Bureau
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.
Regulation | 24/06/2026 | By News Bureau
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.
Regulation | 24/06/2026 | By News Bureau
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.
Regulation | 24/06/2026 | By News Bureau
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