News about "Medicines and Healthcare Products Regulatory Agenc"

UK Sees Surge in Clinical Trials as MHRA Unveils Faster Approval Pathways

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 149

WuXi Biologics' Wuxi Facilities Receive MHRA GMP Approval for Ophthalmic Biologic Manufacturing

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 133

Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis

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 167

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

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 284

CuraTeQ Biologics Secures UK MHRA Approval for Bevqolva

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 580

Moderna Gets MHRA Authorization for Updated COVID-19 Vaccine

Moderna Gets MHRA Authorization for Updated COVID-19 Vaccine

For the first time in the UK, the updated vaccine, Spikevax JN.1, will also be available to purchase privately for those who are not eligible for the NHS Autumn vaccination program.

Medicines And Healthcare Products Regulatory Agenc | 05/09/2024 | By Aishwarya 387


 

 

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