News about "Medicines and Healthcare Products Regulatory Agenc"

UK MHRA Approves Single-Dose 7.2mg Wegovy Injection for Obesity Treatment

The UK Medicines and Healthcare products Regulatory Agency has approved a single-dose 7.2mg Wegovy pen, simplifying weekly treatment for adults with obesity and a BMI of 30 or higher.

Medicines And Healthcare Products Regulatory Agenc | 15/04/2026 | 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.

Medicines And Healthcare Products Regulatory Agenc | 09/04/2026 | By News Bureau |  148

Medicines and Healthcare products Regulatory Agency Approves Inluriyo for Advanced ER-Positive Breast Cancer

The UK regulator has approved Inluriyo (imlunestrant tosylate) for adults with ER-positive, HER2-negative advanced breast cancer with ESR1 mutations after prior hormone therapy failure.

Medicines And Healthcare Products Regulatory Agenc | 26/02/2026 | By News Bureau |  117

MHRA Approves Brensocatib as First Targeted Treatment for Non-Cystic Fibrosis Bronchiectasis in UK

UK regulator grants marketing authorisation to brensocatib (Brinsupri) for patients aged 12 and above with recurrent non-cystic fibrosis bronchiectasis flare-ups.

Medicines And Healthcare Products Regulatory Agenc | 24/02/2026 | By News Bureau |  262

CStone Pharmaceuticals Secures UK MHRA Approval for Sugemalimab in Stage III NSCLC

The UK Medicines and Healthcare products Regulatory Agency grants a new indication for sugemalimab monotherapy in unresectable Stage III NSCLC, expanding its European footprint and global commercial reach.

Medicines And Healthcare Products Regulatory Agenc | 23/02/2026 | By News Bureau |  169

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.

Medicines And Healthcare Products Regulatory Agenc | 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.

Medicines And Healthcare Products Regulatory Agenc | 13/01/2026 | By News Bureau |  211

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.

Medicines And Healthcare Products Regulatory Agenc | 04/10/2025 | By Dineshwori |  226

BrePco and Piramal Receive UK MHRA Approval for Neoatricon Paediatric Dopamine Formula

Neoatricon, developed by BrePco Biopharma, is an age-appropriate, ready-to-use, sterile solution available in two concentrations: 1.5 mg/mL in a 30 mL vial and a higher strength of 4.5 mg/mL in a 50 mL vial.

Medicines And Healthcare Products Regulatory Agenc | 24/03/2025 | By Aishwarya |  310

CuraTeQ Biologics Secures UK MHRA Approval for Bevqolva

Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins.

Medicines And Healthcare Products Regulatory Agenc | 23/12/2024 | By Aishwarya |  630