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

ArrayPatch Completes Oversubscribed €3.2 Million Seed Financing to Advance Next-Generation Microneedle Therapeutics Nov. 05, 2026 -- ArrayPatch Ltd (“ArrayPatch”), a biotech company developing innovative microneedle-based therapeutics, today announced the successful completion of the second close of its seed financing round, securing an additional €1.6 million, bringing the total raised to €3.2 million. The latest investment comes from impact-focused venture capital firm WakeUp Capital along w

November 5, 2026 - Zenith Epigenetics Ltd. ("Zenith" or the "Company") today announced that the Company has executed a Clinical Trial Collaboration and Supply Agreement ("CTCSA") with Eli Lilly & Company ("Lilly") for the upcoming registration enabling study of ZEN-3694, the Company's clinical oncology candidate, and Lilly's CDK4/6 inhibitor, Verzenio (abemaciclib), for the treatment of NUT carcinoma. Under the terms of the agreement, Zenith will sponsor and conduct the study, and Lilly will sup

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

$133 million Series B financing co-led by new investors Advent Life Sciences and British Business Bank, with additional new investments from Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Samsara BioCapital, M-Ventures and Lilly, joined by all existing major shareholders Proceeds to fund two first-in-class TCR-CD3 bispecific programmes in cancer and autoimmune disease through to clinical proof-of-concept Dr. Kirsty Crame appointed Chief Development Officer to oversee translational and clinic

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.

Egetis Therapeutics’ lead asset, EMCITATE®, isthe first and only approved treatment in U.S. and Europe for peripheral thyrotoxicosis associated with MCT8 deficiency, a rare genetic disorder, impacting approximately 1 in 70K males Supported by ANI’s proven track record in Rare Disease, EMCITATE® has potential to reach over $300 million in peak sales in its approved indication, with U.S. and EU Orphan Drug Exclusivity and patent protection into 2045 Combines ANI’s resources, Rare Disease expertise