Tags : FDA

Regulatory

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA

Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP […]Read More

Regulatory

Jazz’s Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Receives the US FDA’s

Shots: The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged ≥1mos. with ALL or LBL who are allergic to the E. coli-derived asparaginase. Rylaze has approved under the RTOR program Additionally, recent data from a Children’s Oncology Group retrospective analysis in ~8,000 patients […]Read More