WuXi Biologics Achieves Major Regulatory Milestone with FDA Pre-License Inspection Clearance for Five Facilities, Including First Commercial Pre-Filled Syringe Site WuXi Biologics (HKEX: 2269), a global leader in Contract Research, Development, and Manufacturing Organization (CRDMO) services, has reached a significant…
Sarepta Therapeutics Responds to FDA’s Voluntary Halt Request for ELEVIDYS Shipments and Clarifies Gene Therapy Safety Concerns Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a leading biotechnology company at the forefront of developing precision genetic medicines for rare neuromuscular diseases, issued a…
Propel Health Appoints Veteran Communications Executive Jeff Keller as President of Medical Affairs Business Unit, Signaling Strategic Expansion in Life Sciences Engagement Propel Health, a premier provider of strategic communications and engagement solutions for the life sciences industry, has announced…
Astellas and Korea’s KISED Forge Strategic Alliance to Support Global Expansion of Drug Discovery Startups Astellas Pharma Inc. (TSE: 4503) has entered into a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED), a key…
KalVista Pharmaceuticals Secures UK MHRA Approval for EKTERLY® (sebetralstat), Paving the Way for First Oral On-Demand Treatment for Hereditary Angioedema in the Region KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), a clinical-stage pharmaceutical company focused on developing innovative oral therapies for rare…
JCR Pharmaceuticals and Acumen Pharmaceuticals Forge Strategic Partnership to Develop a Blood-Brain Barrier-Penetrating Alzheimer’s Therapy Using J-Brain Cargo® Platform JCR Pharmaceuticals Co., Ltd. (TSE: 4552), a Japan-based global specialty biopharmaceutical company renowned for its focus on rare and genetic diseases,…
New Guidelines Expand Access to Advanced Liver Imaging and Transplant Evaluations Using Contrast-Enhanced Ultrasound A new policy change is being hailed by medical experts as a transformative advancement in the diagnosis and management of liver disease, particularly for patients suffering…
Baxdrostat Achieves Positive Results in Phase III BaxHTN Trial, Demonstrating Significant Blood Pressure Reduction in Patients with Uncontrolled or Resistant Hypertension AstraZeneca has announced promising top-line results from its pivotal Phase III BaxHTN clinical trial evaluating the efficacy and safety…
WHO’s International Pathogen Surveillance Network Launches Communities of Practice to Advance Genomic Surveillance The World Health Organization’s (WHO) Hub for Pandemic and Epidemic Intelligence has taken a major step forward in strengthening global health preparedness through the International Pathogen Surveillance…
Burundi Eliminates Trachoma as a Public Health Problem, Marking Major Milestone in Disease Control The World Health Organization (WHO) has officially validated that Burundi has eliminated trachoma as a public health problem, becoming the eighth country in the WHO African…
WHO-WIPO-WTO Webinar Highlights Role of Public Procurement in Advancing Global Health Equity and Innovation On July 3, 2025, the World Health Organization (WHO), the World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO) jointly hosted a technical webinar…
Capricor Shares Tumble After FDA Rejects Cell Therapy for Duchenne Cardiomyopathy Over Efficacy Concerns Capricor Therapeutics suffered a major regulatory setback Friday after the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) rejecting its investigational cell…
