Clinical research
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
Psychedelics therapies – serotonin 2 A receptor agonists – are trying to enter mainstream medicine for depression and as anti-inflammatory or neuroprotective treatments.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Bristol Myers Squibb and Exelixis reported two-year follow-up data from the Phase III trial of BMS’s checkpoint inhibitor Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib).
The unspoken challenge is: how diverse can a trial run in the United States really be right now?
Roivant Sciences launches new subsidiary Hemavant that will develop Eisai-licensed asset for transfusion-dependent anemia in patients with low-risk MDS.
Six months after the one-time treatment, 47% of patients in Cohort 1 demonstrated a promising two-step or greater improvement in their diabetic retinopathy.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
ProQR Therapeutics has reported that their drug sepofarsen failed to meet its primary and secondary endpoints in recent Phase II/III clinical trials.
The planned testing for DNL919 was held back pending additional documentation required to initiate the studies and information on the preclinical toxicology assessment.
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