US FDA rejects approval of Unicycive’s kidney disease therapy
This decision was issued in a Complete Response Letter (CRL) which cited deficiencies at a third-party manufacturing facility producing OLC. The FDA did not raise concerns related to
The European Commission has granted approval for Novartis’ Itvisma (onasemnogene abeparvovec) as a treatment for children two years and older, teenagers and adults who have 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene.
The partnership will combine Combotope’s SMART-Phage discovery platform with Boehringer Ingelheim’s research and development capabilities, focusing on multiple identified oncology targets. Combotope CEO Ola Blixt said: “At Combotope,