All Blogs
Sep 04, 2026
MIMRYLO Enters the Polycythemia Vera Arena: Can the First-in-Class Hepcidin Mimetic Challenge JAKAFI and BESREMi?
Summary On August 28, 2026, the FDA approved MIMRYLO (rusfertide), developed by Protagonist Therapeutics and commercialized by Takeda, for treating erythrocytosis in adults with polycythemia vera. MIMRYLO is the first approved hepcidin mimetic peptide for PV. It targets the iron-regulation pathway rather tha...
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Sep 03, 2026
Spineart’s PERLA® TL Application Receives FDA 510(k) Clearance for eCential Robotics’ Op.n® Platform; Alcon’s Clareon Monofocal IOL Earns EU MDR Certification; BTL Expands Into Laser Technology With New Division and EXOLASE ONE; Stryker, IAGE Collaborate to Enhance Fluorescence-Guided Surgery Training in India; Galmed Announces Positive First-in-Human Results for Colospan’s Novel Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial
Spineart and eCential Robotics received FDA 510(k) Clearance for the PERLA® TL Application for Use with the eCential® Op.n® Navigation System for Robotic Procedures On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n Na...
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Sep 02, 2026
Leadless Pacemakers: The Shift Toward Wire-Free Cardiac Pacing
Cardiac arrhythmias remain one of the most persistent burdens on global healthcare systems, and reliable pacing therapy continues to be the backbone of treatment for bradycardia and related conduction disorders. As the world's population ages and the prevalence of cardiovascular disease climbs, the demand for safer...
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Sep 01, 2026
Takeda’s MIMRYLO Wins U.S. FDA Approval for Polycythemia Vera; Lilly’s Mounjaro Gains FDA Approval for Cardiovascular Risk Reduction in Type 2 Diabetes; Teva Expands Neuroscience Portfolio Through Proposed Acquisition; BioNTech Ends Phase 2 Study of Autogene Cevumeran in Colorectal Cancer; AusperBio Secures $120 Million Series C to Advance AHB-137 and Next-Generation Hepatitis B Therapies
Takeda Gains FDA Approval for MIMRYLO Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for MIMRYLO™ (rusfertide) to treat erythrocytosis in adults with polycythemia vera (PV), a type of blood cancer. MIMRYLO is a first-in-class hepcidin mimetic develop...
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Aug 31, 2026
Orexin Receptor Agonists: A Promising New Wave in Narcolepsy Treatment
Summary For decades, narcolepsy drugs only managed symptoms (stimulants, sodium oxybate, wake-promoters); none addressed the underlying biology. In 2026, orexin receptor agonists changed the game by directly replacing the missing orexin signal that causes narcolepsy type 1 (NT1). On August 5, 2026, the FDA a...
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Aug 27, 2026
Spineart and eCential Robotics Gain FDA Clearance for PERLA® TL Robotic Surgery Application; ZEISS CLINIC 360 Earns FDA 510(k) Clearance, Strengthening Data-Driven Patient Care; Bittium Introduces Faros Pro™ and EasyFlex™ for Extended Ambulatory ECG Monitoring; Cytrellis Expands ellacor® Micro-Coring® Technology to Australia for Full-Body Skin Resurfacing; Galmed Announces Successful First-in-Human Study of Colospan’s Novel Tissue Assessment Technology; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial
Spineart and eCential Robotics Received FDA 510(k) Clearance for the PERLA® TL Application for Use with eCential® Op.n® Navigation System for Robotic Procedures On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n ...
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Aug 28, 2026
The Next Wave in Peripheral T-Cell Lymphoma Treatment: 4 Late-Stage Drugs Making Their Mark
Summary Peripheral T-cell lymphoma (PTCL) is a rare and aggressive group of mature T-cell malignancies, representing approximately 10–15% of non-Hodgkin lymphomas in the US. CHOP remains the standard first-line treatment, but its intensive cytotoxic profile limits use in some patients. ADCETRIS (brentuxi...
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Aug 26, 2026
From COVID-19 to Seasonal Influenza: Is mRNA Vaccine Technology Entering Its Second Act?
In August 2026, the U.S. FDA approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based seasonal influenza vaccine, for adults aged 50 and older, the first flu shot in history built on the same messenger-RNA platform that powered the COVID-19 response. It is, by Moderna's own count, the company's fourth approved U.S. prod...
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Aug 25, 2026
US FDA Grants Priority Review to Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer; Amylyx’s Avexitide Achieves Positive Topline Results in Phase 3 LUCIDITY Study; Ultragenyx Marks Major Milestone as FDA Approves GENGLYCOS for GSDIa; Pasatru Receives FDA Approval for Fibrodysplasia Ossificans Progressiva; Merck and Moderna’s Intismeran Autogene Plus KEYTRUDA Delivers Positive Phase 3 Results in Resected Melanoma
GSK’s Jemperli Granted FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer GSK plc announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Jemperli (dostarlimab) as a potential treatment for patients with pre...
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Aug 24, 2026
BMS Claims the First CELMoD Crown as ZENBEXUS Raises the Stakes in Multiple Myeloma Treatment
Summary In August 2026, the FDA granted accelerated approval to Bristol Myers Squibb’s ZENBEXUS (iberdomide), the first-in-class CELMoD, in combination with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy. Approval rests on the Phase 3 EXCAL...
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