An August 5 public meeting convened by the Reagan-Udall Foundation for the FDA examined how approved medicines could …
An August 5 public meeting convened by the Reagan-Udall Foundation for the FDA examined how approved medicines could …
The new autoinjector delivers an IV-equivalent 80 mg furosemide dose at home, and MannKind paired the approval with …
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 …
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