Protocol teams can invest months in expert review and still face costly amendments, frozen enrollment and delayed Phase III ...

Clinical trials are the irreplaceable engine of drug development and a bedrock of modern medicine, yet patient enrollment ...

The agency explicitly stated that the trial’s current primary endpoint is “not an appropriate endpoint to demonstrate efficacy.” ・As a result, the FDA no longer considers the study to be “pivotal.” ...

Review authors suggested guidelines to help in standardizing future lupus nephritis studies. Heterogeneity in lupus nephritis (LN) trial design substantially hinders interpretation of studied drugs’ ...

Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include ...

The development of oligonucleotide (ON) drugs such as antisense ONs and siRNAs has accelerated rapidly and is highly sought after, with increasing diversity in modalities and applications. The use of ...

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...

A significant unmet need exists for new and effective treatments for urothelial cancers (UCs). To identify optimal treatment options and improve outcomes for patients, trial design is of utmost ...

Clinical trials are notoriously expensive, time consuming, and risky. Failure comes at a very high cost (millions of dollars and months of development time wasted), yet studies show that the rate of ...

Design Therapeutics, Inc. announced the initiation of a Phase 1 clinical trial for its gene-targeted treatment DT-216P2 in healthy volunteers, with patient dosing for Friedreich Ataxia (FA) set to ...