Clinical Trials Insight
New drug applications for Bayer’s FXIa inhibitor accepted by US Food and Drug Administration under priority review and by Japan’s Ministry of Health, Labour...
Bayer has announced that the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare...
New analysis shows Tryngolza (olezarsen) reduced acute pancreatitis by 85% and triglycerides by 66% in severe hypertriglyceridemia
Sobi has announced results from a new analysis of the pivotal phase 3 trials, showing Tryngolza® (olezarsen) reduced the...
BioLineRx and Hemispherian announce new data demonstrating potent anti-tumour effect in Glioblastoma (GBM) across multiple in vivo studies
BioLineRx, a clinical development stage biopharmaceutical company, and Hemispherian, a clinical-stage oncology company developing novel small molecule therapeutics, have...
Orexo announces positive outcome from in vivo study of OX390
Orexo AB has announced positive data from a pre-clinical in vivo study on the nasal absorption of atipamezole when...
Myosin Therapeutics initiates phase 1/2 trial of MT-125 targeting non-muscle myosin II in newly diagnosed glioblastoma
Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, has announced that the first patient has...
New clinical study shows pasteurised Akkermansia muciniphila MucT supports weight loss maintenance
The Akkermansia company has announced the publication of a new randomised, placebo-controlled clinical trial in Nature Medicine demonstrating that supplementation with pasteurised Akkermansia...
Remepy reports strong clinical phase 2a results for Hybridopa, a first-in-class hybrid drug for Parkinson’s disease
Remepy, a pioneer in hybrid drugs, has announced that the phase 2a clinical trial of Hybridopa, a new hybrid...
BioMarin announces positive phase 3 pivotal study results for Voxzogo (vosoritide) in children with hypochondroplasia
BioMarin Pharmaceutical has announced that a phase 3 study evaluating treatment with Voxzogo® (vosoritide) in children with hypochondroplasia met its...
Eli Lilly’s triple agonist, retatrutide, delivered powerful weight loss in pivotal phase 3 obesity trial
Eli Lilly and Company, the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), has announced positive topline results from a...
Kelun-Biotech announces phase 3 trial of Sacituzumab Tirumotecan versus chemotherapy as first-line treatment for advanced TNBC met primary endpoint of PFS
Kelun-Biotech Biopharmaceutical has announced that the Independent Data Monitoring Committee (IDMC) concluded that the phase 3 clinical study of...
Positive topline results from a phase 3 trial for VGX-3100 in cervical dysplasia patients announced by ApolloBio, INOVIO’s partner in China
Inovio, a biotechnology company focused on developing and commercialising DNA medicines to help treat and protect people from HPV-related...
Allergan Aesthetics receives positive CHMP opinion for Boey® (TrenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults
Allergan Aesthetics has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has...
Positive topline results from the pivotal phase 3 study of pozdeutinurad in gout
Sobi has announced positive topline results from a pivotal phase 3 study evaluating pozdeutinurad (AR882), an investigational next-generation once-daily...
Innovent Biologics’ new bispecific fusion protein demonstrates robust survival benefits in long-term follow-up study in advanced immunotherapy-resistant non-small-cell lung cancer
Innovent Biologics has announced updated data from the phase 1 clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363...
US FDA IND clearance for localised fat reduction candidate, a second global phase 3 study of Caliway’s CBL-514
The Investigational New Drug (IND) application for CBL-0302 (Supreme-02), Caliway's second multi-country pivotal phase 3 study for its localised...
AbbVie announces positive CHMP opinion for Maviret (glecaprevir/pibrentasvir) for the treatment of acute Hepatitis C infection
AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive...
Rznomics reports interim clinical data for RZ-001 in hepatocellular carcinoma, demonstrating encouraging efficacy and favourable safety profile
Rznomics has presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in...
Calla Lily doses first patients in clinical trial for intravaginal drug delivery platform for threatened miscarriage
Calla Lily Clinical Care, a women’s health-focused medical technology company, has announced dosing of the first patients in the...
Inhibrx provides clinical update on ozekibart in late line colorectal cancer
Inhibrx Biosciences, a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, has released updated interim data from...
Positive phase 1 data for RAG-17 in amyotrophic lateral sclerosis patients with mutations in the superoxide dismutase 1 gene
Ractigen Therapeutics, a clinical-stage biopharmaceutical company focused on developing next-generation RNA-based medicines, has announced positive preliminary data from the...
Dayspring Pharma announces phase 2 trial of CG2001 foam met primary endpoint in Chinese adult men with androgenetic alopecia
Dayspring Pharma has announced top-line data from its phase 2 clinical trial of CG2001 foam in male patients with...
Novo Nordisk to seek oral sickle cell therapy approval after phase 3 success
A phase 3 trial of Novo Nordisk’s once-daily tablet has met both co-primary endpoints, reducing vaso-occlusive crises (VOC) and...
Ledger Run first to bring AI-powered automation to clinical trial payments
Ledger Run, a leader in clinical trial financial management solutions, has announced significant upgrades to its ClinRun platform, including intelligent automation...
AstraZeneca to seek accelerated approval of Ultomirisin in immunoglobulin A nephropathy on phase 3 data
AstraZeneca plans to seek accelerated approval of Ultomirisin kidney disease after the drug showed benefit after just 34 weeks,...
Tenvie doses first subject in phase 1 TNV108 trial for peripheral neuropathies
Tenvie Therapeutics has dosed the first participant in its phase 1 clinical trial of TNV108 to treat peripheral neuropathies.
The...
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