News about "MHRA"

UK MHRA Secures EUro 3.6 Million to Expand AI Airlock for Safer Medical AI Innovation

Backed by multi-year government funding, the UK’s first AI medical device regulatory sandbox will scale real-world testing, strengthen oversight and accelerate safe adoption of clinical AI technologies.

MHRA | 09/04/2026 | By News Bureau |  148

MHRA and FDA Partner to Fast-Track Innovative Medical Devices for Patients

The Medicines and Healthcare products Regulatory Agency (MHRA) is strengthening its collaboration with the US Food and Drug Administration (FDA) to accelerate patient access to safe and innovative medical technologies in both the United Kingdom and the United States.

MHRA | 06/04/2026 | By Darshana

MHRA Clears Deuruxolitinib (Leqselvi) by Sun Pharma for Severe Alopecia Areata in Adults

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) for treating severe Alopecia Areata in adults, granting authorisation to Sun Pharma UK via the International Recognition Procedure (IRP).

MHRA | 13/03/2026 | By News Bureau

UK Space Agency Launches Initiative to Accelerate Development of Space-Manufactured Medicines

UK Space Agency, with Medicines and Healthcare products Regulatory Agency and partners, unveils regulatory support and innovation programmes to help companies develop microgravity-manufactured medicines and bring them from orbit to patients.

MHRA | 07/03/2026 | By News Bureau

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 |  186

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 |  242

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 |  211

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 |  237

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 |  139

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 |  245