Category Regulatory

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…

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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…

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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…

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BMS’s Anti-Tau Antibody PRX005 Gets FDA Fast Track for Alzheimer’s

BMS’s Anti-Tau Antibody PRX005 Gets FDA Fast Track for Alzheimer’s

Prothena Corporation plc announced that its partner, Bristol Myers Squibb (BMS), has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for BMS-986446 (PRX005), an investigational anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 clinical development…

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