ReAlta Life Sciences Publishes Preclinical Data Showing RLS-0071 Reduces Brain Inflammation in Neonatal Hypoxic-Ischemic Encephalopathy Model ReAlta Life Sciences, Inc., a clinical-stage biopharmaceutical company advancing therapies that rebalance the body’s inflammatory response, has announced the publication of new preclinical findings…
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…
Wedgewood Expands and Evolves Its Veterinary Advisory Committee with the Launch of Two New Councils to Strengthen Clinical Collaboration and Strategic Insight Wedgewood, a long-standing leader in veterinary pharmacy and a trusted partner to veterinary professionals across the United States,…
Merck and SpringWorks Secure Conditional EU Approval for EZMEKLY®, the First Therapy for NF1-Associated Plexiform Neurofibromas in Both Adults and Children Merck, a global leader in science and technology, announced that the European Commission (EC) has granted conditional marketing authorization…
Genascence Secures RMAT Designation for Groundbreaking Gene Therapy GNSC-001 in Knee Osteoarthritis, Signaling a Major Step Forward in Regenerative Medicine Genascence Corporation, a clinical-stage biotechnology company pioneering gene therapy solutions for chronic musculoskeletal diseases, announced that the U.S. Food and…
Vistagen Earns Dual Honors for Mental Health Advocacy and Exceptional Workplace Culture in 2025 Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company revolutionizing neuroscience with its novel nose-to-brain neurocircuitry platform, has achieved significant recognition for its employee-centered workplace practices. The…
Reflow Medical Receives FDA De Novo Clearance for Spur Stent System, Marking a Breakthrough in Treatment of Below-the-Knee Peripheral Arterial Disease Reflow Medical, Inc., a pioneering company in the development of advanced medical devices for complex cardiovascular conditions, has announced…
Samsung Bioepis Unveils European Policy Whitepaper to Bridge Gaps Hindering Biosimilar Access and Market Sustainability Samsung Bioepis Co., Ltd. has published a comprehensive whitepaper titled “Solving the Biosimilar Void in Europe,” aiming to drive reform in biosimilar policy frameworks across…
Moderna Secures Full FDA Approval for Spikevax in High-Risk Children Amid Growing mRNA Scrutiny Moderna has scored another key regulatory milestone as the U.S. Food and Drug Administration (FDA) granted full approval for the company’s COVID-19 vaccine, Spikevax, for use…
FDA Approves Merck Animal Health’s BRAVECTO® QUANTUM, a Year-Long Injectable Flea and Tick Treatment for Dogs Merck Animal Health, a division of Merck & Co., announced FDA approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension)—a once-yearly injectable treatment for…
Merck’s NDA for Once-Daily Doravirine/Islatravir HIV Regimen Accepted by U.S. FDA Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an…
FDA Accepts sNDA for INQOVI® Plus Venetoclax for Newly Diagnosed AML Patients Ineligible for Intensive ChemotherapyCombination therapy met primary efficacy endpoint with no new safety signals; would represent the first all-oral regimen for this patient population if approved Taiho Pharmaceutical…