Category Regulatory

Arrowhead

Arrowhead’s Subsidiary Visirna Sells China Rights for Plozasiran to Sanofi

Arrowhead’s Subsidiary Visirna Transfers Greater China Rights to Plozasiran to Sanofi in Strategic $395 Million Deal Amid Regulatory Milestone in Hypertriglyceridemia In a move poised to reshape the therapeutic landscape for patients with severe lipid disorders in China, Arrowhead Pharmaceuticals,…

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BeOne

BeOne’s BGB-16673 Earns EMA PRIME Status for Waldenstrom’s Macroglobulinemia

BeOne Medicines Achieves Key Regulatory Milestone as EMA Grants PRIME Designation to BTK Degrader BGB-16673 for Waldenstrom’s Macroglobulinemia BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), an emerging global player in oncology therapeutics, has reached a critical milestone in…

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Actio Biosciences Secures FDA IND Clearance and Fast Track for ABS-1230 in KCNT1 Epilepsy

Actio Biosciences Receives FDA IND Clearance and Fast Track Designation for ABS-1230 in KCNT1-Related Epilepsy, Marking Major Advancement in Pediatric Precision Medicine Actio Biosciences, a clinical-stage biotechnology company pioneering novel therapies through the lens of genetics and precision medicine, has…

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Stallergenes Greer’s Palforzia® Spotlighted on Lifetime TV’s “The Balancing Act”

Stallergenes Greer Brings National Spotlight to Peanut Allergy Awareness with Palforzia® Segment on Lifetime TV’s “The Balancing Act” Stallergenes Greer, a global biopharmaceutical company and recognized leader in allergy immunotherapy (AIT), recently announced a major milestone in its public awareness…

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AGC Biologics Heidelberg to Supply Drug Substance for Valneva’s Phase II Shigella Vaccine

AGC Biologics’ Heidelberg Facility to Manufacture Drug Substance for Phase II Trials of Valneva’s Four-Valent Shigella Vaccine Candidate AGC Biologics, a global contract development and manufacturing organization (CDMO), announced a new partnership with specialty vaccine company Valneva SE (Nasdaq: VALN;…

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Simulations Plus and Polish Academy Validate AI-Powered ADMET Predictor® Models

Simulations Plus and Polish Academy Scientists Validate AI-Powered Drug Design Models in Breakthrough Discovery Targeting Inflammation and Immune Regulation Simulations Plus, Inc. (Nasdaq: SLP), a prominent developer of modeling and simulation software for the biopharmaceutical industry, in collaboration with the…

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Biocytogen Enhances Preclinical Services and Unveils Redesigned Global Website

Biocytogen Elevates Preclinical Research Services and Global Engagement with Strategic Platform Upgrade and Website Relaunch Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKEX: 02315), a pioneering force in the biotechnology sector known for its cutting-edge antibody discovery and preclinical services, has taken…

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DiaMedica Therapeutics Closes $30.1 Million Private Placement to Advance Clinical Programs

DiaMedica Therapeutics Secures $30.1 Million in Oversubscribed Private Placement to Bolster Advancement of Neurological and Maternal Health Pipeline Proceeds strengthen company’s financial runway as it targets innovative treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke DiaMedica Therapeutics Inc.…

Read MoreDiaMedica Therapeutics Closes $30.1 Million Private Placement to Advance Clinical Programs

Crossbow Therapeutics Nominates Second Cancer Drug Candidate, CBX-663

Crossbow Therapeutics Advances Second TCR-Mimetic Cancer Therapy Candidate, CBX-663, Targeting TERT Across Broad Range of Tumors Crossbow Therapeutics, Inc., a biotechnology company pioneering a new class of T-cell receptor (TCR)-mimetic antibody therapeutics through its proprietary T-Bolt™ platform, has announced the…

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