All Blogs
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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Aug 01, 2025
Overcoming Adherence Challenges in Growth Hormone Deficiency Treatment: The Promise of Long-Acting and Oral Therapies
Growth hormone deficiency (GHD) is a rare condition that arises from inadequate secretion of growth hormone by the anterior pituitary gland. It can originate from birth (congenital), develop later in life (acquired), or occur without a known cause (idiopathic), underscoring the complex mix of genetic, environmental...
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Jul 31, 2025
Philips Secures FDA Nod for Image-Guided Platform in Prostate Cancer Treatment; Roche Gains CE Mark for Alzheimer’s Screening Blood Test; CorTec Completes First Human Implantation of Its Brain-Computer Interface in Neurotech Breakthrough; Natera Initiates ABCSG 61 Trial to Assess Signatera™ in Early-Stage Breast Cancer; GE HealthCare Introduces Advanced Digital X-ray System to Enhance Imaging Accessibility in High-Volume Settings; Stryker-Owned Inari Medical Launches InThrill® System for AV-Access and Small Vessel Thrombus Treatment
Philips Secured FDA 510(k) Clearance for Image-Guided Navigation Technology, Advancing Minimally Invasive Prostate Cancer Treatment On July 23, 2025, Philips, a global leader in health technology, announced a significant milestone in prostate cancer care with the U.S. FDA 510(k) clearance of the latest ver...
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