News about "MHRA"

Eisai seeks UK Approval for Insomnia Therapy Lemborexant

Eisai has submitted lemborexant for regulatory review in the UK, aiming to expand treatment options for adults suffering from chronic insomnia and improve patients' daytime functioning.

MHRA | 04/07/2026 | By News Bureau

Regulators Warn against Promotion of Newly Licensed Weight-Loss Medicines

MHRA, ASA, and GPhC have warned businesses against promoting newly licensed prescription-only and unlicensed weight-loss medicines, reinforcing compliance with advertising regulations and public health protections.

MHRA | 20/06/2026 | By News Bureau

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 |  249

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 |  151

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 |  123

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 |  136

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 |  257

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 |  377

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 |  243

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 |  280