Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery compared to placebo AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurrence Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 i

Feb. 23, 2026 -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, today announced the publication of a manuscript titled Template-Directed RIG-I Agonist Assembly for Image-guided Targeted Cancer Immunotherapy in the journal Molecular Imaging and Biology. The paper, published February 19, 2026, reports on a novel tumor-selective immunotherapy approach that activates innate imm

First patient dosed in Phase 1b randomized, placebo-controlled study evaluating safety, tolerability and weight loss over 12 weeks Market research indicates strong demand for ketogenic-metabolic approaches, including among adults with obesity who are not currently receiving treatment BL-001 positioned as a potential oral ketogenic-metabolic therapy designed for gradual, sustained weight loss with improved tolerability Feb. 24, 2026 -- Bloom Science, Inc., a clinical-stage biotech company focuse

Looking to redeem its IL-17A/F nanobody after a mixed showing in hidradenitis suppurativa (HS) last year, MoonLake Immunotherapeutics unveiled Phase II data Monday for sonelokimab that it believes could change the treatment paradigm in axial spondyloarthritis (axSpA). The 12-week S-OLARIS study enrolled patients with both the radiographic and non-radiographic forms of the chronic inflammatory spine disease. According to topline results, 81% of treated patients (n=26) achieved at least a 40% imp

Feb. 23, 2026 -- Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, its lead in vivo gene editing program. TSRA-196 is being jointly developed with Regeneron for the treatment of adults with alpha-1 antitrypsin deficiency (AATD) who are homozygous for the PiZ allele (PiZZ). TSRA-196 is designed to pr

Approval expands low-dose MRI contrast options for the youngest patients and reflects a positive benefit–risk profile of VUEWAY® injection from birth through adulthood Feb. 23, 2026 -- Bracco, a global leader in diagnostic imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the current VUEWAY® (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants. VUEWAY® injection is a macrocyclic gadolinium-based contrast a

February 23, 2026 -- Vidac Pharma Holdings Plc. announces that the first patient has been successfully enrolled and dosed in its Phase 2b clinical study evaluating VDA-1102 for the treatment of highly proliferative lesions of Actinic Keratosis (AK). The initiation of patient dosing follows completion of applicable regulatory requirements, importation of the investigational medicinal product, and training of the medical team at Centroderm GmbH (Wuppertal, Germany). This milestone marks an import

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