Game-changing cancer therapy: Imugene’s VAXINIA receives FDA orphan drug status for bile tract cancer
Imugene Limited has received a significant boost with the United States Food and Drug Administration (FDA) granting Orphan Drug Designation (ODD) to its experimental therapy, ... Read More
Telix Pharmaceuticals submits NDA for Pixclara to advance brain cancer imaging
Telix Pharmaceuticals Limited (ASX: TLX) has taken a significant step in the realm of neuro-oncology by submitting a New Drug Application (NDA) to the U.S. ... Read More
Phanes Therapeutics’ PT217 receives FDA orphan drug designation for neuroendocrine carcinoma
Phanes Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing oncology treatments, has achieved a significant milestone with the granting of Orphan Drug Designation (ODD) ... Read More
Alexion Pharmaceuticals secures FDA priority review for SOLIRIS in neuromyelitis optica spectrum disorder
Alexion Pharmaceuticals has secured a significant milestone with the FDA granting priority review for its C5 complement inhibitor, SOLIRIS (eculizumab), as a treatment for neuromyelitis ... Read More
Biohaven secures orphan drug status for verdiperstat in MSA treatment
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for its investigational drug verdiperstat for treating multiple ... Read More
Mereo BioPharma completes patient enrollment for BPS-804 Phase 2b trial in osteogenesis imperfecta
British specialty biopharma company Mereo BioPharma Group has completed patient enrollment for a Phase 2b clinical trial of its human monoclonal antibody BPS-804, also known ... Read More