Following approval by the European Commission (EC), sugemalimab has received a new indication approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for stage III non-small cell lung cancer (NSCLC). This marks the second indication approved for the product in the UK. This approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial. Results demonstrated that sugemalimab provided statistically significant improvement in progression-

The FDA approved AstraZeneca's BTK inhibitor Calquence (acalabrutinib) in combination with AbbVie and Roche's BCL-2 inhibitor Venclexta (venetoclax) — also marketed by AbbVie as Venclyxto in the EU — for the first-line treatment of chronic lymphocytic leukaemia (CLL) in adults, establishing the first and only all-oral, fixed-duration combination therapy for previously untreated patients. Also see – Spotlight On: BTK inhibitors move towards fixed-duration combos in CLL. "The…approval expands cho

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement) Feb. 21, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA® (guselkumab

Feb. 20, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI™ demonstrated bioequivalence to iloperidone acros

Selpercatinib demonstrated a highly statistically significant and clinically meaningful improvement in reducing the risk of disease recurrence or death Results from the LIBRETTO-432 trial build on previous results for selpercatinib in advanced NSCLC and reinforce the value of genomic testing at diagnosis and across all stages of disease Feb. 16, 2026 -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatin

Roche announced Monday that a Phase III study of Gazyva/Gazyvaro (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, potentially setting up another approval for the anti-CD20 monoclonal antibody and the first for a therapy in this chronic autoimmune condition. The MAJESTY trial randomised 142 people with primary membranous nephropathy to receive Gazyva/Gazyvaro or tacrolimus. Results showed that significantly more people achieved complete remission at week 104

– MAJESTY, the first global Phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years – – Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this – – Gazyva could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus eryth

Clinical Advisory Board formed to support progression of HRN001 into first-in-human studies in 2027 Dr Andy Billinton, CSO will present preclinical data at the upcoming CHDI Foundation Huntington’s Disease Therapeutics Conference 16 February 2026: Harness Therapeutics (‘Harness’), a biotechnology company unlocking previously undruggable targets to transform the treatment of neurodegenerative diseases, today announces the nomination of HRN001 as its lead drug candidate for Huntington's disease

GLP-1 initiation is associated with a 14.6% reduced risk of asthma exacerbation for overweight patients, 12.2% for obese patients and 13.3% for morbidly obese patients Feb. 15, 2026 -- Glucagon-like peptide-1 receptor agonists (GLP-1) is linked to a significant reduction in asthma exacerbations for overweight, obese and morbidly obese patients without diabetes, according to new research being presented at the 2026 AAAAI Annual Meeting. "Asthma exacerbations can be disruptive for patients, espe

CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a significant milestone in the global development of this innovative immunotherapy. The ongoing global multicenter Phase II trial is currently enrolling patients in Australia and China. The study design includes 15 cohorts evaluating both monotherapy and comb