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China approves Libevitug, first-in-class therapy for hepatitis D

Huahui Health announced that China National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for the treatment of chronic hepatitis D virus infection in adults with or without compensated...

Correction — Privo Technologies

Privo Technologies, Inc. announced the successful completion of its Phase 1/2 clinical evaluation of PRV211, a first-in-class intraoperative chemotherapy patch for head and neck cancer patients. The study demonstrated excellent safety outcomes...

HanchorBio Partners with WuXi Biologics to Advance Next-Generation Fusion Protein Pipeline

HanchorBio, Inc. a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, and WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing...

Lansinoh® Launched NaturalWave® Double Electric Breast Pump Featuring Exclusive Flutter Technology for Increased Milk Output

Lansinoh®, a leader in breastfeeding and maternal care for over four decades, announced the launch of the NaturalWave® Double Electric Breast Pump, a next-generation power pump engineered to solve a major gap in the market: helping moms not just...

Ad Hoc Analyses Indicate Enhanced Survival Outcomes with VYLOY™ (zolbetuximab) Combined with Chemotherapy When Common Adverse Events Are Properly Managed

Astellas Pharma U.S., Inc. announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or...

FDA Approves New 2-Gram Fibryga® Presentation to Improve Convenience and Precision in Treating Acquired Fibrinogen Deficiency

Octapharma USA, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired...

In Europe, Samsung Bioepis begins the commercialization of BYOOVIZ®, a biosimilar to Lucentis (Ranibizumab)

Samsung Bioepis Co., Ltd. announced that the company has begun direct commercialization of BYOOVIZ®, a biosimilar to Lucentis1 (ranibizumab), in Europe. Samsung Bioepis has been working to ensure seamless transfer of commercial rights from Biogen...

Peer-reviewed validation of a 60-channel closed-loop neurostimulation brain implant is published by Nia Therapeutics

Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for closed-loop treatment of memory disorders. The...

Voranigo® (vorasidenib) from Servier has received multiple regional Prix Galien Awards

Servier, an independent international pharmaceutical group governed by a foundation, announced that Voranigo® (vorasidenib) has been awarded the inaugural 2025 Prix Galien Bridges Award for Best Product for Orphan/Rare Diseases, during a ceremony...

Samsung Bioepis Announces the Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

Samsung Bioepis Co., Ltd. announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January...

Menarini Group Shares New Data on ELZONRIS® (tagraxofusp-erzs)

The Menarini Group a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer...

FDA Approves Arrowhead Pharmaceuticals’ REDEMPLO® (plozasiran) for Reducing Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS).

Arrowhead Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial...

Jazz Pharmaceuticals presents new clinical and translational data for Modeyso™ (dordaviprone) in H3 K27M-mutant diffuse midline glioma at SNO 2025

Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and...

New long-term data confirms TREMFYA® (guselkumab) as the only IL-23 inhibitor proven to block joint damage in active psoriatic arthritis

Johnson & Johnson announced new data from the Phase 3b APEX study showing that TREMFYA® continued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks. At Week 24, TREMFYA ®...

Marius Pharmaceuticals has expanded its global footprint with Health Canada’s approval of KYZATREX® (testosterone undecanoate) CIII capsules

Marius Pharmaceuticals, Inc. a patient-centric healthcare company committed to advancing innovative therapies for testosterone deficiency, announced that Health Canada has approved KYZATREX® (testosterone undecanoate) CIII capsules. KYZATREX is a...

The BioTech Breakthrough Award has been granted to Asahi Kasei for the Planova™ FG1 Filter

Asahi Kasei Corporation has earned top honors in the 2025 BioTech Breakthrough Awards, winning the Biomanufacturing Innovation of the Year for its Planova™ FG1 virus removal filter, developed by its Asahi Kasei Bioprocess business unit. Designed...

Odyssey Therapeutics Welcomes Dennis Dean, Ph.D., as EVP, Non-Clinical Development

Odyssey Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that precisely target disease pathology,...

HanchorBio Unveils Compelling New Data at SITC 2025 Highlighting the Best-in-Class Potential of HCB101 in Advanced Cancers

HanchorBio Inc. a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40th...

VTAMA® (tapinarof) Cream, 1%, Demonstrates Early and Consistent Efficacy in Children Aged 2+ with Atopic Dermatitis, According to New Data

Organon a global independent healthcare company with a focus on women’s health, will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2025...

Gilead’s Livdelzi® Shows Sustained Efficacy in PBC, Reducing ALP, Relieving Itch, and Potentially Slowing Disease Progression

Gilead Sciences, Inc. announced new long-term data reinforcing the safety and efficacy profile of Livdelzi® (seladelpar) for people living with primary biliary cholangitis (PBC). Findings support Livdelzi's consistent efficacy and safety outcomes...