FDA Delays Review of BLA Submission for Moderna's Novel Respiratory Syncytial Virus Vaccine
May 10th 2024Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
FDA Accepts sBLA for Bimzelx to Treat Hidradenitis Suppurativa Based on Phase III Trial Data
April 4th 2024In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.