Enrolment in this trial is expected to continue through the first quarter of 2025. Satellos is on track to submit a Phase II ...
Completion of the pharmacokinetics study of AD04 enables the end-of-Phase 2 (EOP2) interaction with the FDA, a crucial step toward advancing to Phase 3 trials. Study results support the planned ...
The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
VYNE Therapeutics (VYNE) announced that the first subject has been dosed in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque ...
The Safety Review Committee overseeing the trial has approved this new cohort following a review of safety and pharmacokinetic ... aligns with preclinical and Phase 0 trial outcomes.
SAB BIO, (“SAB BIO”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human ...
We thank Michèl Willemsen and colleagues for their interest in the ATTeST trial of intra-erythrocyte dexamethasone sodium phosphate in children with ataxia telangiectasia.1 The two doses studied in ...
Study completion enables an End-of-Phase 2 FDA meeting and strengthens ... ADIL announced the completion of the AD04-103 pharmacokinetics (PK) study for AD04, confirming predictable ...
The findings revealed that ondansetron pharmacokinetic exposure increased ... and intends to incorporate their feedback in the End-of-Phase 2 meeting, scheduled in the first half of this year.