All Blogs
Jun 05, 2025
Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs
Guardant Health Secured FDA Breakthrough Device Designation for Its Shield Multi-Cancer Detection Test On June 03, 2025, Guardant Health, Inc., a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to its Shield multi-cancer detectio...
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Jun 04, 2025
Types of Mitochondrial Diseases and the Science Behind Them: A Journey from Dysfunction to Discovery
Mitochondrial diseases, affecting an estimated 1.5 million individuals globally (approximately 1 in 5,000), represent a complex group of rare genetic disorders driven by mitochondrial dysfunction, disrupting cellular energy production. These conditions stem from mutations in mitochondrial DNA (mtDNA) or nuclear DNA...
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Jun 03, 2025
Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia
Beam Therapeutics Secures FDA Orphan Drug Designation for BEAM-302 in AATD Beam Therapeutics Inc. announced that the FDA has granted Orphan Drug Designation to its investigational therapy, BEAM-302, for the treatment of alpha-1 antitrypsin deficiency (AATD). BEAM-302 is a liver-targeting lipid nanoparticle (LNP)...
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Jun 02, 2025
Dry Eye Disease Treatment: A Growing Space with Expanding Therapeutic Options
Dry eye disease (DED) is a common yet often underestimated condition affecting millions worldwide. Characterized by insufficient tear production or poor tear quality, it leads to persistent eye discomfort, irritation, and vision problems. Studies suggest that up to 30% of the adult population may experience some de...
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May 30, 2025
Targeting Multiple Sclerosis: Comparative Insights Across CD20, BTK, S1P, DHODH, and Nurr1
Multiple sclerosis is a chronic, immune-mediated neurodegenerative disorder characterized by inflammation, demyelination, and gradual axonal degeneration within the central nervous system (CNS). While a range of disease-modifying therapies (DMTs) have been approved, many offer limited efficacy in slowing disease pr...
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May 29, 2025
Olympus Gains FDA Clearance for EDOF™ Imaging Endoscopes; FDA Approves Abbott’s Tendyne™ Device for Minimally Invasive Mitral Valve Replacement; New Study Validates Exact Sciences’ Oncodetect™ for Enhanced MRD Detection in Stage II-IV Colorectal Cancer; Sensome Completes First-in-Human Trial Enrollment for Lung Cancer Detection System; J&J MedTech Introduces SOUNDSTAR CRYSTAL™ to US Market with Breakthrough 2D Imaging Quality; Terumo Launches ROADSAVER™ Carotid Stent System to Improve Outcomes in Carotid Artery Stenosis
Olympus Secured FDA Clearance for Cutting-Edge EDOF™ Imaging Endoscopes, Redefining Visibility with Sharper, Blur-Free Views On May 27, 2025, Olympus Corporation, a global leader in medical technology and endoscopic imaging, announced that it received FDA 510(k) clearance for its next-generation EZ1500 series en...
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May 28, 2025
Everything You Need to Know About Niemann-Pick Disease – From Types to Therapies
Niemann-Pick Disease (NPD) is a cluster of rare, genetically inherited lysosomal storage disorders characterized by the pathological accumulation of lipids within various organs. This buildup leads to progressive multisystem dysfunction, with severity and progression varying significantly across subtypes. While ind...
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May 27, 2025
Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011
Gilead’s TRODELVY Demonstrates Significant PFS Benefit in First-Line Metastatic TNBC in ASCENT-03 Trial Gilead Sciences has announced positive topline results from the Phase III ASCENT-03 trial of TRODELVY (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) patients who ar...
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May 26, 2025
Leigh Syndrome Treatment: The Ongoing Quest for an Effective Cure
Leigh syndrome, also called subacute necrotizing encephalomyelopathy, is a rare and serious genetic neurometabolic condition classified as a primary mitochondrial disease. It is associated with mutations in more than 75 genes, most of which are involved in cellular energy production. However, because many cases do ...
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May 23, 2025
Incyte’s Zynyz Secures Approval for Anal Cancer—A Comeback After FDA Rejection
Following two simultaneous FDA approvals, Incyte’s PD-1 inhibitor Zynyz has made a comeback in the treatment of anal cancer, four years after being initially rejected by the agency. On May 15, 2025, Incyte announced that the FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody that targets the PD...
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