Category Regulatory

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…

FDA Approves Label Update for Lilly’s Alzheimer’s Drug Kisunla in Bid to Enhance Safety and Broaden Use The U.S. Food and Drug Administration (FDA) has approved a significant label update for Eli Lilly’s Alzheimer’s drug Kisunla, aimed at addressing persistent…

FDA Greenlights Label Update and Revised Dosing Schedule for Lilly’s Kisunla (donanemab‑azbt) in Early Symptomatic Alzheimer’s Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an updated product label for Kisunla® (donanemab-azbt). This…