All articles tagged with #crl
The FDA issued a Complete Response Letter for Scholar Rock's apitegromab BLA due to manufacturing observations at a third-party facility, but no other approval issues were cited. Scholar Rock plans to resubmit after remediation of the manufacturing concerns, maintaining optimism about the drug's potential to treat SMA.
The FDA released a complete response letter to Lykos Therapeutics' MDMA for PTSD application, citing issues like unreported adverse events, lack of durability data, and high prior MDMA use among participants, and recommended conducting new clinical trials with specific focus areas.
The FDA has rejected ImmunityBio's bladder cancer treatment, Anktiva, due to deficiencies with the company's third-party contract manufacturer. The FDA provided recommendations to resolve specific issues but did not request new preclinical or Phase III studies for safety or efficacy. ImmunityBio has requested a meeting with the regulator to address the Complete Response Letter (CRL) and timeline to resolve issues and "seek approval as expeditiously as possible." The company has a potential partner lined up for the commercialization of Anktiva despite the CRL.