Enhanced Group Applauds FDA Advisory Committee Recommendation Supporting Regulated Access to Therapeutic Peptides Enhanced Group Inc. (NYSE: ENHA), a company focused on elite sports performance, personalized health optimization, and evidence-based longevity solutions, has welcomed a significant regulatory development following a…
Gossamer Bio Advances Toward NDA Submission for Seralutinib, Reacquires Global Rights, and Strengthens Strategic Position Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for pulmonary hypertension, has announced a series of significant regulatory, strategic,…
Crysvita® Approved Across the EU for Infants Living with X-Linked Hypophosphataemia Kyowa Kirin EMEA, a wholly owned subsidiary of Kyowa Kirin Co., Ltd., has announced that the European Commission (EC) has approved an expanded indication for Crysvita® (burosumab), allowing the…
Pilatus Biosciences Receives Hong Kong Clinical Trial Authorization for PLT012 and Expands Asia-Pacific Presence with New Regional Subsidiary Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing innovative metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, has announced two…
Clinigen Appoints Greg Skalicky as Group CEO to Lead Next Phase of Global Growth and Patient Access Strategy Clinigen, a global pharmaceutical services company dedicated to improving patient access to critical medicines around the world, has announced the appointment of…
Aqtual Strengthens Executive Leadership to Advance Active Chromatin cfDNA Diagnostics and Precision Medicine Platform Aqtual, Inc., a precision medicine company focused on developing next-generation diagnostics based on active chromatin cell-free DNA (cfDNA), has announced the appointment of Ferhan Qureshi as…
Corrixr Therapeutics Appoints Nancy Whiting as Board Chair to Support Advancement of CXR101 Toward Clinical Development Corrixr Therapeutics, a preclinical genetic medicine company developing innovative therapies for squamous cell cancers, has announced the appointment of Nancy Whiting, PharmD, as Chair…
Hologic Expands CE-IVDR Approval for Aptima HPV Assay to Support Self-Collected Cervical Cancer Screening Samples Hologic, Inc. has announced that its Aptima® HPV Assay has received an expanded CE-IVDR marking in the European Union and the United Kingdom, allowing the…
OmniAb Appoints Amechi Nwachuku as Chief Operating Officer to Accelerate Growth of xPloration® Single B-Cell Screening Platform OmniAb, Inc., a biotechnology company recognized for its advanced antibody discovery technologies that support the development of next-generation therapeutics, has announced the appointment…
Universal Brain Receives FDA 510(k) Clearance for UB ERP System, Advancing Objective Brain Function Assessment in Mental Health Care Universal Brain, a neurotechnology company focused on developing objective tools to measure brain function for mental health applications, has announced that…
Stoke Therapeutics Appoints Thomas McCauley as Chief Scientific Officer to Advance RNA Medicine Pipeline and Genetic Disease Research Stoke Therapeutics, Inc. has announced the appointment of Thomas McCauley, Ph.D., as its new Chief Scientific Officer (CSO), reinforcing the company’s commitment…
PADCEV® Combination Approved for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility Pfizer Inc. and Astellas Pharma Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv) in combination with the PD-1 inhibitor Keytruda® (pembrolizumab)…