The US Food and Drug Administration (FDA) has granted Roche a label expansion for its ophthalmology therapy, Enspryng (satralizumab), in thyroid eye disease (TED), with the benefit of an at-home administration. This means that the interleukin 6 (IL-6) inhibitor is now greenlit for use in adults with TED – a condition where the body’s own cells attack the muscles, tear glands and connective tissues behind the eyes. Following its label expansion, healthcare providers can now prescribe Enspryng to

The trial met the primary and secondary endpoints with statistically significant placebo-adjusted improvements at Week 3 in the YMRS total score (3.1 points; p=0.045) and CGI-BP Severity of Mania score (0.4 points; p=0.024) RAP-219–treated patients had a 15.4-point mean reduction in YMRS total score from baseline at Week 3 All 11 items measured by the YMRS improved numerically compared to placebo at Week 3, with improvements in irritability, thought content, disruptive-aggressive behavior, and s

Designation covers AV-1959R for people with amyloid buildup in the brain but no symptoms, a population for whom no preventive therapy is approved Fast Track allows more frequent FDA interaction and potential eligibility for rolling review, Accelerated Approval and Priority Review Nuravax plans to evaluate AV-1959R in AREVIA, a 160-participant Phase 2 prevention study Oct. 20, 2026 -- Nuravax, Inc., a clinical-stage biotechnology company developing vaccines for neurodegenerative diseases, today

Four abstracts accepted for presentation at European Society for Medical Oncology (ESMO) 2026 demonstrate the breadth of clinical development across multiple tumor types and treatment settings Oct. 19, 2026 -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that four abstracts for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented at the European Society for Medical Oncolog

– Peer-Reviewed Paper Introducing QRX003 and Its Mechanism of Action in Netherton Syndrome Now Published – Case Report Details 21 Months of Compassionate Use Treatment in a Pediatric Patient – Patient’s Skin Improved from Severe to Clear with Complete Elimination of Pruritus (itch) – After 21 Months of Treatment with QRX003, Patient’s Skin Remains Fully Clear and Pruritus Free – No Adverse Events have Been Reported for the Patient – Full Recruitment in Ongoing Phase 2/3 Netherton Syndrome Study

- Clearance enables initiation of SHIELD-AL, a pivotal study in newly diagnosed patients with lambda AL amyloidosis - Investigational oral light chain stabilizer to be evaluated as an add-on to standard-of-care plasma cell-directed therapy Oct. 19, 2026 -- Protego Biopharma, Inc., a clinical-stage biotechnology company developing small molecule therapies for protein misfolding diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IN

Positive Phase 1 data were previously presented in an oral session at ASCO 2026 Emi-Le received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation Oct. 19, 2026 -- Servier today announced the first patients have been dosed in the pivotal Phase 2 cohort (EMBLEM-1) of a Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in solid tu

OptimUM-01 and OptimUM-02 data supports the broad potential of darovasertib plus crizotinib to drive meaningful clinical benefits for patients with metastatic uveal melanoma, irrespective of HLA-A*02:01 allele status or line of therapy OptimUM-01 data demonstrates encouraging clinical activity from darovasertib combined with crizotinib in both treatment-naïve (7.4 month PFS, 27.1 month mOS, n=13) and heavily pretreated HLA-A*02:01-positive metastatic uveal melanoma, including in 2L patients foll

Immunocore announces first patient dosed in the Phase 1 trial ofIMC-S118AI – its first tissue-specific autoimmune candidate – for patients with type 1 diabetes The Phase 1 trial will assess the safety and clinical activity of IMC-S118AI in HLA-A*02:01-positive patients with type 1 diabetes Preclinical data supporting unique mechanism of action recently published in Science Advances 15 October 2026 Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotech

Patient recruitment completed six months ahead of schedule in two global Phase III trials for migraine prevention MINT-E and MINT-C are evaluating XEOMIN® (incobotulinumtoxinA) for the preventive treatment of episodic and chronic migraine Trials recruited approximately 1,800 adults across 109 study sites in North America and Europe Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, today announced the completion of patient recruitment in two global Phase III clinica