All Blogs
Aug 14, 2025
Nyxoah Secures FDA Nod for Genio® System in OSA Treatment; FDA Grants First 510(k) Clearance to DeepSight™-Powered NeedleVue™ LC1 Ultrasound System; TITAN CSR® Retractor Tops U.S. Military List for Trauma Care in Deployed Settings; FDA Clears Myra Vision to Begin US IDE Study for Glaucoma; HistoIndex Advances Fibrosis Assessment with AI-Powered FibroSIGHT™ Plus; Gentuity Partners with GE HealthCare to Broaden Access to Cutting-Edge Intravascular Imaging
FDA Approves Nyxoah’s Genio® System for Treating Obstructive Sleep Apnea On August 08, 2025, Nyxoah SA, a medical technology company that developed breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the U.S. Food and Drug Administration (FDA) had a...
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Aug 13, 2025
Top 5 Big Data Applications in Healthcare Revolutionizing Patient Care
Over the past decade, big data in healthcare has evolved from a promising concept into a transformative force reshaping patient care, clinical research, and hospital operations. What began as fragmented data stored in electronic health records has now expanded into massive, interconnected datasets drawn from wearab...
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Aug 12, 2025
Teva’s AJOVY Expanded by FDA as First Anti-CGRP Preventive for Pediatric Episodic Migraine; NRx Pharma’s NRX-100 Granted FDA Fast Track for Suicidal Ideation in Depression/Bipolar Depression; Boehringer Ingelheim’s HERNEXEOS Wins FDA Accelerated Approval for HER2-Mutant Advanced NSCLC; Genmab’s Phase III EPCORE FL-1 Meets Dual Endpoints in Relapsed/Refractory Follicular Lymphoma; Tiziana’s Phase II IND Cleared by FDA for Multiple System Atrophy
FDA Expands Teva’s AJOVY As First Anti-CGRP Preventive For Pediatric Episodic Migraine Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the FDA has approved AJOVY (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescents aged 6–...
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Aug 11, 2025
The Next Wave in Sarcopenia Drug Development: 5 Therapies to Look Out
Although there are no approved sarcopenia drugs at present, ongoing research is exploring possible pharmacological solutions. Investigational treatments include Selective Androgen Receptor Modulators (SARMs) and myostatin inhibitors, which aim to enhance muscle mass and function. Beyond non-pharmacological approach...
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Aug 08, 2025
Narcolepsy Treatment Market Awakens: A Projected Boom Fueled by Emerging Therapies
Narcolepsy is a chronic neurological disorder that disrupts the brain’s ability to regulate sleep-wake cycles. Often misunderstood and underdiagnosed, it typically begins in adolescence but may remain unrecognized for years. The hallmark symptoms include Excessive Daytime Sleepiness (EDS), sudden muscle weakness, v...
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Aug 07, 2025
SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division
SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its Se...
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Aug 06, 2025
From Sight to Insight: The Rise of Smart Ophthalmological Devices in Eye Care
Ophthalmology devices are specialized medical instruments and equipment designed for the diagnosis, treatment, and management of eye-related conditions and disorders. These devices encompass a wide range of technologies, including diagnostic tools like optical coherence tomography (OCT) scanners and fundus cameras,...
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Jul 22, 2025
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck’s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn’s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences’ PMN310 for Alzheimer’s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths Sarepta Therapeutics, Inc. has voluntarily and temporarily paused all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling u...
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Aug 05, 2025
Anbogen’s ABT-301 Cleared by FDA for Phase I/II Colorectal Cancer Trial; Dyne’s DYNE-251 Gets FDA Breakthrough Tag for Duchenne Muscular Dystrophy; BMS’s BREYANZI Accepted for FDA Priority Review in MZL; Clarametyx’s CMTX-101 Earns FDA Fast Track and QIDP for Infections; Anixa Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial
Anbogen Secures FDA Nod to Begin Phase I/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer Anbogen Therapeutics has received FDA clearance to initiate a Phase I/II clinical trial of ABT-301 in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). The study w...
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Aug 04, 2025
Hashimoto’s Thyroiditis Treatment: Addressing the Therapeutic Void with New Alternatives
Hashimoto’s thyroiditis is an autoimmune disorder in which the immune system mistakenly attacks the thyroid gland, leading to persistent inflammation, gland enlargement, and the development of autoantibodies targeting thyroid proteins. Formerly known as “struma lymphomatosa,” it is now recognized as the leading cau...
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