Category Regulatory

Clustermarket Rebrands as Calira, Appoints Industry Veteran

Clustermarket Rebrands as Calira, Appoints Industry Veteran to Drive R&D Lab Optimization

Calira, formerly known as Clustermarket, has announced a major rebrand and the appointment of Edmund Wilson, co-founder and former CEO of Titian Software (now Cenevo), as a non-executive director and investor. The move underscores Calira’s strategy to strengthen its position…

Read MoreClustermarket Rebrands as Calira, Appoints Industry Veteran to Drive R&D Lab Optimization
MaaT Pharma Reports Positive Safety Update from Phase 2b PHOEBUS Trial

MaaT Pharma Reports Positive Safety Update from Phase 2b PHOEBUS Trial of MaaT033 in Allo-HSCT Patients

MaaT Pharma, a clinical-stage biotechnology company pioneering Microbiome Ecosystem Therapies™ (MET) to improve survival outcomes in patients with cancer through immune modulation, today announced the successful completion of the second pre-planned safety interim analysis of its ongoing Phase 2b PHOEBUS…

Read MoreMaaT Pharma Reports Positive Safety Update from Phase 2b PHOEBUS Trial of MaaT033 in Allo-HSCT Patients
FDA Grants Fast Track to Alto’s ALTO-101 for Schizophrenia

FDA Grants Fast Track to Alto’s ALTO-101 for Schizophrenia-Related Cognitive Impairment

Alto Neuroscience, Inc., a clinical-stage biopharmaceutical company pioneering precision medicines for neuropsychiatric disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). This…

Read MoreFDA Grants Fast Track to Alto’s ALTO-101 for Schizophrenia-Related Cognitive Impairment
FDA OKs Tecentriq + Lurbinectedin for First-Line Maintenance in ES-SCLC

FDA OKs Tecentriq + Lurbinectedin for First-Line Maintenance in ES-SCLC

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adults with extensive-stage small…

Read MoreFDA OKs Tecentriq + Lurbinectedin for First-Line Maintenance in ES-SCLC