Oct. 12, 2026 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States. Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and va

Collaboration expands access to Lunit's AI-powered pathology platform by combining it with Discovery Life Sciences' global biospecimen and specialty laboratory capabilities, enabling standardized tissue insights for biomarker research and drug development. Oct. 12, 2026 -- Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced a strategic collaboration with Discovery Life Sciences (Discovery), a global leader in biospecimens and specialty la

RESTORE is evaluating NVG-291’s potential to improve hand function and quality of life in individuals living with chronic cervical motor-incomplete spinal cord injury Study builds on functional improvements observed in the placebo-controlled Phase 1b/2a CONNECT SCI study, with FDA alignment on the Phase 3 registrational design Enrollment completion anticipated in the second half of 2027; topline data expected in the first half of 2028 Oct. 12, 2026 -- NervGen (NASDAQ: NGEN), a late-stage clinic

In Cycle-1REF Phase 2 clinical trial, tovinontrine demonstrated substantial reduction in NT-proBNP, a biomarker for heart failure, in patients with HFrEF on top of guideline-directed medical therapy, with a favorable safety and tolerability profile Company continues to advance tovinontrine in a pioneering clinical program targeting PDE9 in heart failure Results from the Cycle Phase 2 clinical trials will be presented in a plenary session at Heart Failure Society of America Annual Scientific Meet

The HARNESS-1 Safety Review Committee identified no dose-limiting toxicities or treatment-related safety concerns in either Cohort 1 patient during the safety observation period and has recommended the trial proceed to the next planned dose level of RC220 in combination with osimertinib. Oct. 12, 2026 -- Racura Oncology Limited (ASX: RAC), a late clinical-stage biopharmaceutical company developing new small molecule-based approaches to cancer treatment focused on silencing MYC gene expression,

Final analysis of 109 patients from 18 German centres demonstrates durable treatment outcomes in routine clinical practice1 Median time-to-next-treatment(TTNT), the study's primary endpoint, was 14.9 months, alongside a 62.4% best overall response rate, 20.2-month overall median progression-free survival and improved quality of life from baseline reported in routine care1 Exploratory analyses show meaningful responses in clinically relevant subgroups, including large cell transformation, follicu

Viatris will acquire the rights to Exparel and Zilretta if this acquisition goes ahead. Credit: Dragana Gordic / Shutterstock.com. California-based healthcare company Viatris has inked a billion-dollar deal to acquire Pacira BioSciences and its non-opioid pain management therapies – allowing the company to enter a market attracting growing attention amid the ongoing effects from the opioid crisis in the US. Through this deal, Viatris will pay $36.50 in cash per share for Pacira’s remaining stock

About six months after Japanese drugmaker Asahi Kasei bought Aicuris for about €780 million, the treatment at the centre of the takeout has won FDA approval. The US regulator on Friday cleared Hovilpri (pritelivir), a helicase primase inhibitor, to treat immunocompromised patients who have mucocutaneous lesions caused by herpes simplex virus (HSV) that don't respond to standard-of-care therapies like acyclovir, valacyclovir or famciclovir. Asahi Kasei had proposed to acquire Aicuris in February,

Oct. 12, 2026 -- T-MAXIMUM PHARMACEUTICAL ("T-MAXIMUM") today announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate a Phase 2 clinical study of MT027, its internally developed, B7-H3-targeted universal (allogeneic) CAR-T therapy, for the treatment of patients with brain metastases from lung cancer and breast cancer. This is the second Phase 2 study of MT027 to receive FDA clearance. MT027 was previously cleared by the FDA to proceed with a Phase 2 study

New data show favorable outcomes with subcutaneous infliximab following intravenous infliximab interruption, regardless of prior antibody status, in adult patients with moderate to severely active Crohn's disease and ulcerative colitis Late-breaking analysis shows significantly higher rates of clinical remission and improved endoscopic outcomes with subcutaneous versus intravenous infliximab in patients with ileum-dominant Crohn's disease Oct. 11, 2026 -- Celltrion USA, Inc. today announced t