Research & Development
Alto Neuroscience receives FDA Fast Track designation for ALTO-101
3 October 2025 - Clinical-stage biopharmaceutical company Alto Neuroscience Inc (NYSE:ANRO) announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation to ALT...
Calico Life Sciences' investigational treatment for ADPKD receives US FDA Fast Track Designation
3 October 2025 - Alphabet-founded research and development company Calico Life Sciences LLC announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track Designation for ...
Jazz Pharmaceuticals' Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination approved by FDA in ES-SCLC
3 October 2025 - Ireland-based pharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) announced on Thursday that the US Food and Drug Administration (FDA) has granted approval for Zepzelca (lur...
Hologic receives FDA clearance and CE mark for new gastrointestinal bacterial assays
2 October 2025 - Women's health company Hologic Inc (Nasdaq:HOLX) on Thursday announced US FDA 510(k) clearance and European CE marking for its Panther Fusion Gastrointestinal (GI) Bacterial and ...
Celltrion launches AVTOZMA IV in the United States following FDA approval
2 October 2025 - South Korea-based Celltrion, Inc., a global biopharmaceutical company, announced on Thursday that it has launched AVTOZMA (CT-P47, tocilizumab-anoh) intravenous formulation in the Uni...
Vanda Pharmaceuticals agrees collaborative framework to resolve US FDA disputes
2 October 2025 - US-based pharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq:VNDA) announced on Wednesday that it has agreed on a collaborative framework with the US Food and Drug Administration...