FDA assigns a PDUFA target action date of April 9, 2027 Combination achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months Nov. 05, 2026 -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, today announced the U.S. Food and Drug Administration (FDA) acknowl

Jyseleca® (filgotinib) has received expanded approval for the treatment of patients with active axial spondylarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have not responded adequately to conventional therapy. EC approval follows a positive opinion from the CHMP in September 2026 and offers a new treatment option for people living with inadequately controlled axSpA in Europe. An application has been submitted to the MHRA for UK approval and is under review.

CLD-423 Phase 1a Single- and Multiple-Dose Data Demonstrate Favorable Tolerability and Immunogenicity Profiles and Sustained Target Engagement, Supporting Planned Phase 2 Trials in Ulcerative Colitis and Crohn’s Disease in Early 2027 Exclusive Worldwide License for IL-17 x TL1A Bispecific Antibody Program Expands Pipeline of Novel Investigational Therapies for Immune-Mediated Diseases Caldera Therapeutics, Inc. (Caldera), a privately held clinical-stage biotechnology company developing bispecif

— Selective SIK2 inhibitors reduced disease activity in a mouse model of rheumatoid arthritis to levels comparable to approved therapies etanercept and upadacitinib — November 5, 2026 — Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a computational drug discovery company developing breakthrough small molecule medicines through advanced structure-based design and AI-enabled chemistry, today announced that it will present new preclinical data from its highly selective salt-inducibl

In the Phase 1b/2 trial, zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, demonstrated clinically meaningful responses in patients with previously treated advanced extrapulmonary neuroendocrine carcinomas (epNECs), with a confirmed objective response rate (ORR) of 40.0% and a median duration of response (mDOR) of 5.6 months Results indicate responses to zoci monotherapy treatment among multiple epNEC subtypes, including gastroenteropancreatic NEC (GEP-NEC) and other epNEC

Johnson & Johnson won a label expansion for the subcutaneous formulation of its EGFR/MET inhibitor on Thursday. The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a second-line treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), broadening its reach beyond non–small-lung cancer. The regulatory nod, granted following a priority review, is the first for a dual-targeted therapy in the specific HNSCC setting.

— Eligible for development incentives including 7 years of US market exclusivity upon regulatory approval — — Marks the second US FDA Orphan Drug Designation for sovleplenib, following its recent designation for primary ITP — Nov. 04, 2026 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the US Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia (“AIHA”). Sovleplenib is

The completed Phase 1a study data in healthy volunteers showed early signs of pharmacodynamic activity supporting further clinical evaluation of RES-010 The Phase 1b study in healthy overweight and moderately obese participants is ongoing with data expected in H1 2027 November 05, 2026 – Resalis Therapeutics today announced topline data from the first-in-human study of its lead candidate, RES-010, a novel antisense oligonucleotide targeting microRNA-22 (miR-22). RES-010 is designed to address t

Impressive early anti-tumour activity and a therapy-leading safety pro in heavily pretreated patients across multiple B-cell lymphoma subtypes Objective response rate of 53% in 17 efficacy evaluable patients, including responses in patients previously treated with CD19-directed CAR-T cell therapy Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), today announces the presentation of preliminary data from the dose escalation portion of its Phase 1 study

Both doses of CBT-001 demonstrated statistically significant improvements in conjunctival hyperemia at Month 3 versus vehicle (p<0.001), with improvement observed as early as Week 2 and maintained through Month 12 Both doses also demonstrated statistically significant prevention of progression of pterygium lesion length at Month 12 versus vehicle (p<0.001) Superficial punctate keratitis was reported in 20% of patients receiving CBT-001 0.1%, compared with 8% receiving vehicle; the majority