CStone Pharmaceuticals’ Sugemalimab bags UK nods for Stage III NSCLC

Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause

FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients

FDA nod to first-ever treatment for fatal pediatric Menkes disease

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations

Ipsen’s FALKON trial falls short in rare FOP study, offers key insights

FOP is a rare genetic disorder caused by mutations in the ALK2 kinase

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis