All Blogs
Apr 15, 2025
Cellenkos’ CK0801 Granted FDA Orphan Drug Status for Aplastic Anemia; Mirum’s LIVMARLI Gets FDA Nod for Tablet Formulation; SynOx’s Emactuzumab Earns FDA Fast Track for TGCT; Bristol Myers Squibb’s OPDIVO + YERVOY Combo Approved by FDA for First-Line Advanced Liver Cancer; Soleno Launches VYKAT XR, the First FDA-Approved Therapy for PWS-Related Hyperphagia
Cellenkos’ CK0801 Granted FDA Orphan Drug Designation for Aplastic Anemia Cellenkos® Inc. announced that the FDA has granted Orphan Drug Designation to CK0801, its off-the-shelf, allogeneic T regulatory (Treg) cell therapy, for the treatment of Aplastic Anemia—a rare and life-threatening bone marrow failure diso...
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Apr 14, 2025
Redefining Liver Disease in the Metabolic Era: From NASH to MASH and the Rise of Obesity‐targeted Therapies
The paradigm shift from Non‐alcoholic Steatohepatitis (NASH) to Metabolic Dysfunction–associated Steatohepatitis (MASH) reflects a deeper understanding of the pathophysiology underpinning liver injury in the context of obesity, diabetes, and metabolic syndrome. This evolving nomenclature from NASH to MASH is more t...
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Apr 11, 2025
Prader-Willi Syndrome Drug Market Heats Up: 5 Upcoming Challengers to Soleno’s VYKAT XR
Since the FDA approved recombinant human growth hormone (rhGH) for Prader-Willi syndrome in 2000, numerous companies have faced challenges in developing more advanced treatments for hyperphagia, the uncontrollable hunger associated with PWS. However, in March 2025, Soleno Therapeutics marked a major milestone wi...
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Apr 10, 2025
Ventris Medical Secures Additional FDA Clearance for Backpack® Bone Graft in Intervertebral Disc Applications; Orthocell Gains FDA 510(k) Clearance for Remplir™; ICU Medical Launches New Infusion Device Category with FDA-Cleared Plum Solo™ and Plum Duo™ IV Pumps; Anaconda Biomed Kicks Off U.S. Enrollment for ATHENA Trial Testing ANA Funnel Catheter in Stroke Care; OrthoPediatrics Expands Scoliosis Portfolio with Launch of Innovative VerteGlide™ System; 3D Systems Powers World’s First On-Site Facial Implant Manufacturing at Point-of-Care
Ventris Medical Received Additional FDA Clearance for Backpack® Bone Graft in the Intervertebral Disc Space On April 08, 2025, Ventris Medical, a privately held leader in orthobiologics and tissue regeneration, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance fo...
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Apr 09, 2025
AI-Driven Diagnostics: Why are They the Next Big Thing in Healthcare?
Just a few years back, imagining a machine detecting a heart attack before symptoms surfaced or spotting a tumor more accurately than the human eye sounded like science fiction. Today, it’s just another day in AI-powered healthcare diagnostics. Artificial Intelligence is no longer a distant promise; it's a livin...
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Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
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Apr 07, 2025
Sanofi’s Qfitlia Enters the Hemophilia Market—What Sets It Apart?
Over the past three years, the FDA has approved six new hemophilia treatments, including three gene therapies. Now, Sanofi’s Qfitlia (fitusiran) enters the competitive hemophilia therapeutics market, distinguishing itself as the only therapy approved for all types of hemophilia. Unlike most existing treatments, Qfi...
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Apr 04, 2025
Advances in Prader-Willi Syndrome Treatment: New Hope for Patients
Prader-Willi Syndrome is a complex genetic disorder characterized by a variety of symptoms, including hyperphagia, obesity, and behavioral issues. According to the Prader-Willi Syndrome Association USA, the disorder affects approximately 1 in every 15,000 live births, with more than 300,000 people impacted globally...
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Apr 03, 2025
Abbott Secures CE Mark for Volt™ Pulsed Field Ablation System and Unveils TRILUMINATE™ Trial Data on TriClip™ for Tricuspid Valve Repair; Zimmer Biomet’s RibFix Advantage® Fixation System Earns CE Mark; Teleflex Announces Initial Clinical Data from IDE Study Evaluating Ringer™ PBC in Coronary Perforation Treatment; GE HealthCare Launches Revolution™ Vibe CT, Bringing Unlimited One-Beat Cardiac Imaging and AI Solutions; TELA Bio Launches Larger OviTex® PRS Sizes in the U.S.
Abbott Received CE Mark for Volt™ Pulsed Field Ablation System, Offering New Therapy Option for Heart Rhythm Disorders On March 27, 2025, Abbott announced that it received the CE Mark in Europe for its VoltTM Pulsed Field Ablation (PFA) System, designed to treat patients with atrial fibrillation (AFib). Th...
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Apr 02, 2025
Revolutionary Advances and Bright New Horizons in Multiple Myeloma Treatment
Multiple myeloma, a complex blood cancer rooted in the bone marrow, affects 160K people globally each year, with a mortality rate of 106K. According to DelveInsight, nearly 75K new cases were reported across seven major markets in 2023, a figure expected to climb in the coming years. Yet, amid these sobering statis...
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