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News about "MHRA"
Alvotech Reaches Global Settlement on Eylea Biosimilar
The settlement enables Alvotech and its partners to launch the biosimilar from January 1, 2026 in the UK and Canada, from May 1, 2026 in the EEA and other markets outside the US, and in Japan from May 2026 for select indications, expanding to all approved indications from November 1, 2026.
MHRA | 30/01/2026 | By News Bureau | 135
UK Sees Surge in Clinical Trials as MHRA Unveils Faster Approval Pathways
UK is boosting its global clinical trials appeal through rising trial activity and new fast-track MHRA regulations, enabling quicker approvals, earlier patient access and increased investment.
MHRA | 14/01/2026 | By News Bureau | 149
WuXi Biologics' Wuxi Facilities Receive MHRA GMP Approval for Ophthalmic Biologic Manufacturing
The UK regulator has certified WuXi Biologics’ DP5 and DPPC sites in Wuxi for commercial production, reinforcing the company’s global GMP-compliant manufacturing capabilities.
MHRA | 13/01/2026 | By News Bureau | 133
MHRA Approves New mRNA COVID-19 Booster
The new approved vaccine, Zapomeran (Kostaive) is cleared for adults aged 18 years and above.
MHRA | 05/01/2026 | By News Bureau | 165
Glenmark Secures Exclusive Multi-Region Rights to Aumolertinib from Hansoh Pharma
Glenmark has entered into an exclusive licensing agreement with Hansoh Pharma to commercialise aumolertinib, a third-generation EGFR-TKI approved by the MHRA and China’s NMPA, across multiple international markets, reinforcing the company’s oncology portfolio and expansion strategy in high-growth regions.
MHRA | 17/12/2025 | By News Bureau
Relonchem Gets MHRA Nod for Exemestane 25 mg Tablets
Exemestane by Relonchem, a subsidiary of Markans Pharma, is an aromatase inhibitor used in the treatment of hormone-dependent breast cancer in postmenopausal women. The approval marks another milestone in Marksans Pharma’s strategy to expand its oncology portfolio and strengthen its presence in the UK and European markets.
MHRA | 05/11/2025 | By Dineshwori | 193
Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis
Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.
MHRA | 04/10/2025 | By Dineshwori | 167
IPA Set to Host 8th Global Pharmaceutical Quality Summit, Focusing on 'Patient Centricity - A New Manufacturing and Quality Paradigm
MHRA | 14/06/2023 | By Sudeep Soparkar | 915
Celadon Pharma's UK-based facility bags GMP registration by MHRA
Celadon's medicinal cannabis product will be supplied in oil form as an API
MHRA | 17/01/2023 | By Sudeep Soparkar | 837
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