Category Regulatory

Planet

Planet DDS 2026 Dental Outlook Reports More New Patients and Fewer No-Shows Across the Industry

Planet DDS 2026 Dental Outlook Shows More New Patients, Fewer No-Shows Across the Industry Planet DDS, a leading provider of cloud-based, enterprise-grade dental software solutions, announced the release of its 2026 Dental Industry Outlook, an annual benchmark report designed to help…

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Veristat

Veristat Broadens Regulatory and Clinical Services for Chinese Companies Seeking EU Market Entry

Veristat Expands Regulatory and Clinical Services to Chinese Drug and Device Companies Seeking Efficient Way to Enter European Markets Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced expanded regulatory and clinical trial services to…

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Biosciences

First Patient Dosed in Emalex Biosciences’ Expanded Access Program for Investigational Tourette Syndrome Therapy

First Patient Dosed in Emalex Biosciences’ Expanded Access Program for Investigational Tourette Syndrome Therapy Emalex Biosciences today announced that the first patient was dosed in its Expanded Access Program for ecopipam, an investigational first-in-class D1 receptor antagonist in development for…

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Enhertu Receives U.S. Priority Review for Post-Neoadjuvant Treatment of HER2-Positive Early Breast Cancer

Enhertu receives U.S. Priority Review as a post-neoadjuvant therapy for patients with early-stage HER2-positive breast cancer. AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment…

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European Commission Approves Zynyz for First-Line Treatment of Advanced Anal Cancer, Says Incyte

European Commission Approves Zynyz® (retifanlimab) as a First-Line Treatment for Patients with Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) Incyte has announced that the European Commission has granted approval for Zynyz (retifanlimab) to be used in combination with…

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Mirum

Mirum Pharmaceuticals Provides AZURE Clinical Program Update for Brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals Provides AZURE Clinical Program Update for brelovitug in Chronic Hepatitis Delta Virus Mirum Pharmaceuticals, Inc. a leading rare disease company, today announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase…

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Silence Therapeutics

Silence Therapeutics Highlights Recent Business Achievements and Reports Fourth Quarter and Full-Year 2025 Financial Results

Silence Therapeutics Highlights Recent Business Achievements and Reports Fourth Quarter and Full Year 2025 Financial Results Silence Therapeutics plc, a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today reported financial results for the fourth quarter and full…

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Vasomune

Vasomune Therapeutics, Inc. and AnGes, Inc. Secure FDA IND Clearance

Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients Vasomune Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced U.S. Food and Drug Administration…

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Liberate Medical

Liberate Medical Reaches Full Enrollment Milestone in 250-Patient PREVENT Study Assessing VentFree®

Liberate Medical Completes Enrollment of 250-Patient PREVENT Pivotal Trial Evaluating VentFree® Respiratory Muscle Stimulator Liberate Medical, a clinical-stage medical device company developing breakthrough neuromuscular electrical stimulation (NMES) technology for mechanically ventilated ICU patients, today announced the completion of enrollment in…

Read MoreLiberate Medical Reaches Full Enrollment Milestone in 250-Patient PREVENT Study Assessing VentFree®