Browsing Tag
MHRA
27 posts
FDA lifts hold on Rein Therapeutics’ LTI-03 trial, reviving hopes for idiopathic pulmonary fibrosis treatment
FDA clears Rein Therapeutics to restart its Phase 2 trial of LTI-03 for idiopathic pulmonary fibrosis, restoring investor confidence and trial momentum.
Belite Bio wins UK MHRA nod to file conditional marketing application for tinlarebant in Stargardt disease
Find out how Belite Bio gained UK MHRA backing to file a conditional marketing application for tinlarebant, advancing the first potential therapy for Stargardt disease.
OS Therapies eyes global approvals for OST-HER2 after breakthrough osteosarcoma vaccine trial
OS Therapies’ OST-HER2 cancer vaccine shows strong survival gains in Phase IIb osteosarcoma trial—discover what comes next for global approval.
Regulatory breakthrough: What the MHRA–FDA tie-up means for medtech approvals
Find out how the MHRA–FDA collaboration is reshaping medical device regulation, AI safety, and faster patient access across the UK and US healthcare systems.
FDA acceptance of Sarfaraz Niazi’s biosimilar petition could reset the economics of monoclonal antibody approvals
FDA accepts Sarfaraz Niazi’s petition to waive costly clinical efficacy studies for monoclonal antibody biosimilars, reshaping drug affordability worldwide.
UK approves first-ever immunotherapy for type 1 diabetes — can teplizumab really delay onset by three years?
MHRA approves teplizumab, the UK’s first immunotherapy for type 1 diabetes, delaying onset by three years. See how it could reshape care pathways.
How UK’s new point-of-care drug manufacturing rules will transform cancer and gene therapies
The UK’s world-first point-of-care manufacturing law transforms advanced therapy delivery—discover how it changes cancer and gene therapy access.
MHRA approves Bayer’s Lynkuet as first non-hormonal treatment for menopause hot flushes
Bayer’s Lynkuet becomes the world’s first approved non-hormonal menopause pill. Find out what MHRA’s decision means for women’s health today.
Stablepharma begins world’s first fridge-free vaccine trials; Is the cold chain era ending?
Stablepharma launches the first-ever fridge-free vaccine trial for tetanus and diphtheria—SPVX02—potentially reshaping global vaccine distribution forever.
Piramal Pharma expands into paediatric critical care with UK approval for Neoatricon
Piramal Pharma’s Neoatricon secures UK approval, revolutionizing paediatric critical care. Learn how this breakthrough will reshape neonatal hypotension treatment.