New real-world data guidance could accelerate drug approvals
The MHRA’s consultation, announced on International Clinical Trials, is intended to support creation of innovative UK clinical trials.
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The MHRA’s consultation, announced on International Clinical Trials, is intended to support creation of innovative UK clinical trials.
If approved, the oral medicine could provide a first-in-class treatment option for eligible individuals with the chronic 24-hour disease.
The unique mechanism of action of efimosfermin supports its potential as a new standard-of-care in liver disease.
14 May 2025 | By
The use of AI technology in unifying clinical data across systems for making clinical trials more effective, safer and more efficient.
The novel cell therapy utilises a shortened manufacturing process compared to standard production timelines, offering potential for enhanced therapeutic capability.
The biologic delivered sustained remission in adults with the inflammatory bowel disease (IBD) over the two-year study, results show.
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
The merger deal between Novartis AG and Regulus Therapeutics is expected to push forward development of a potential first-in-class kidney disease drug.
The partnership between Eli Lilly and Company and Creyon Bio will focus on producing safer, more effective RNA-targeted oligonucleotide therapies with the use of AI technology.
The collaboration between Boehringer Ingelheim and Tessellate Bio seeks to address availability of targeted medicines for a cancer type shown to be difficult to treat.
The findings suggest that the biologic treatment could improve short-term outcomes for patients with lupus nephritis.
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
Subject to regulatory approval, the small molecule drug could provide a new treatment option for diabetes and obesity, Eli Lilly’s new data suggests.
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
A clinical trial is currently investigating the potential of CD40L-enhanced tumour-infiltrating lymphocyte (TIL) cancer therapy in non-small cell lung cancer.