Browsing Tag
MHRA
21 posts
UK fast-tracks clinical trials with 14-day reviews and AI simulation support to regain R&D edge
Find out how MHRA’s 2026 trial reforms—fast-track routes, AI models, and 14-day reviews—aim to make the UK a global leader in clinical research again.
Biocon Biologics (NSE: BIOCON) clears global aflibercept deal with Regeneron, Bayer for Yesafili rollout
Biocon Biologics secures global aflibercept launch rights for Yesafili after Regeneron–Bayer settlement. Find out what this means for biosimilar strategy.
Roche’s breast cancer pill inavolisib approved by MHRA for metastatic disease
MHRA approves inavolisib for advanced HR-positive breast cancer. Find out how Roche’s targeted therapy expands treatment options for UK patients.
Leqembi UK approval: BioArctic, Eisai win MHRA nod for once-monthly Alzheimer’s treatment
BioArctic’s Leqembi now approved for monthly IV use in UK Alzheimer’s patients. Find out what this means for long-term treatment worldwide.
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.