Bluebird bio has received word from the FDA that its gene therapy candidate, lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (SCD), won’t undergo an advisory committee review. This development was made public by the company on Wednesday. The Biologics License Application (BLA) for Lovo-cel is currently in the regulatory assessment phase, with the FDA’s decision […]
On Friday, the FDA gave the nod to Janssen Pharmaceutical’s combination of niraparib and abiraterone acetate, branded as Akeega, designed to treat metastatic castration-resistant prostate cancer in patients with the BRCA mutation. Janssen, a branch of Johnson & Johnson, revealed that Akeega is the inaugural dual-function tablet fusing the capabilities of a PARP inhibitor and […]
The FDA has postponed its decision on Valneva’s chikungunya vaccine candidate, VLA1553, moving the PDUFA action date to the end of November, as confirmed by Valneva on Monday. The initial decision was scheduled for the end of August. This extension was granted to provide ample time to harmonize and finalize a phase 4 trial, essential […]