Gene-edited cell therapy exagamglogene autotemcel extends to pediatric patients as young as two, based on trial data showing …
Gene-edited cell therapy exagamglogene autotemcel extends to pediatric patients as young as two, based on trial data showing …
The supplemental approval for exagamglogene autotemcel gives families of children with recurrent vaso-occlusive crises a one-time gene-editing option …
The donor-derived cell therapy is designed to be infused alongside a stem cell transplant, aiming to reduce a …
Phase 3 ARTISTRY-1 and ARTISTRY-2 data support an NDA for a single-tablet HIV regimen combining a capsid inhibitor …
Capivasertib plus abiraterone and prednisone clears regulatory hurdle for a molecularly defined patient population with limited prior options, …
Tebipenem pivoxil hydrobromide clears regulatory hurdle on resubmission, offering hospitalized patients an oral alternative to intravenous imipenem-cilastatin
Arvinas’ vepdegestrant (VEPPANU) demonstrated a 43% reduction in risk of disease progression versus fulvestrant in the pivotal VERITAC-2 …
Shionogi’s ensitrelvir becomes the only approved oral option for preventing COVID-19 following known exposure, filling a gap left …
One company faces regulatory setback while another achieves a Phase III victory, highlighting both urgency and uncertainty in …
Regulatory setback for one biotech contrasts with a major success in sleep disorder treatment, underscoring the high stakes …
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