An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
No new studies have been requested
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal
Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
The first clinical trial is expected to commence in early 2022 both in Europe and the US
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
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