24% ORR for BI-1808 combined with pembrolizumab represents a meaningful improvement over pembrolizumab monotherapy in recurrent ovarian cancer (8% ORR in KEYNOTE-100) The combination demonstrated a favorable safety and tolerability profile Results suggest that this combination could deliver a new immuno-oncology option for this population with high unmet need BioInvent will expand the ovarian cancer cohort by enrolling an additional 20 patients focusing on high-grade serous and clear cell subtyp

NEW YORK, Jan. 02, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (“INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the closing of its previously announced private placement with two healthcare focused institutional investors priced at-the-market under Nasdaq rules of 2,298,850 shares of common stock (or pre-funded warrants in lieu thereof), Series K-1 warrants to purchase up to an aggr

With the rise of biologics, precision medicine, and AI-driven drug discovery, clinical research has entered a new and complex era. As advanced therapiesincluding cell and gene therapies (CGTs) and specialized treatments for rare diseasemake up an increasing percentage of the pipeline, eligible patient populations are shrinking. Generating meaningful evidence from smaller cohorts can be easier with innovative trial designs, so single-arm, adaptive, and basket protocols are becoming more common. I

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has accepted the Company’s IND for COYA 302 for the treatment of frontotemporal dementia (FTD). FTD is the most common form of dementia in people under the age of 65, affecting about 6

NEW YORK, Jan. 01, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that as foreshadowed at the recent Annual General Meeting the Board will undertake a number of changes in line with the Company's evolution to a revenue-generating commercial company. Having presided during the most transformational period for the company with its first U.S. Food & Drug Administration (FDA) approval and su

GAITHERSBURG, Md., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH). Breakthrough Therapy Designation is i

Acquisition adds complementary asset to the Pelthos commercial portfolio Xeglyze is a novel, FDA-approved prescription medication indicated for the topical treatment of head lice infestation in patients 6 months of age and older DURHAM, N.C., Jan. 05, 2026 (GLOBE NEWSWIRE) — Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced it has acquired Xeglyze® (abameta

24% ORR for BI-1808 combined with pembrolizumab represents a meaningful improvement over pembrolizumab monotherapy in recurrent ovarian cancer (8% ORR in KEYNOTE-100) The combination demonstrated a favorable safety and tolerability profile Results suggest that this combination could deliver a new immuno-oncology option for this population with high unmet need BioInvent will expand the ovarian cancer cohort by enrolling an additional 20 patients focusing on high-grade serous and clear cell subtyp

-The Phase II study for diabetes is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with diabetes. Enrollment is expected to begin in the first quarter of 2026. -ASC30 demonstrated placebo-adjusted weight loss of 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or overweight, with better gastrointestinal tolerability. No hepatic safety signal was observe

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted for 2026 DUBLIN, Jan. 05, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that the U.S. Food and Drug Administration (FDA) has