All Blogs
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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May 22, 2025
FDA Clears Fujirebio’s Lumipulse® G Plasma Test for Detecting Alzheimer’s-Linked Amyloid Pathology; Stryker Gains FDA Clearance for OptaBlate® BVN System to Treat Chronic Low Back Pain; Abbott Unveils Clinical Evidence Linking Libre® CGM to Reduced Cardiovascular Events in Diabetes; GE HealthCare Launches AI-Based CleaRecon DL for Enhanced 3D Reconstruction in Interventional Suites; Philips Advances Cardiac Care with Launch of RADIQAL Clinical Study and Real-Time 3D Intracardiac Imaging Catheter in Europe
Fujirebio Received FDA Clearance for Innovative Lumipulse® G Plasma Biomarker Test, Marking Major Advancement in Identifying Amyloid Pathology Linked to Alzheimer’s Disease On May 16, 2025, Fujirebio announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Lumipulse® G pT...
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May 21, 2025
Unveiling Lysosomal Storage Disorders: Exploring Rare Diseases Impacting Millions Worldwide
Lysosomal Storage Disorders, or LSDs, are rare genetic conditions that may not make headlines, but they affect thousands worldwide, often with life-changing consequences. LSDs happen when the body’s lysosomes, tiny cellular recycling centers, fail to break down waste materials due to missing or faulty enzymes. This...
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May 20, 2025
Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+
Incyte’s ZYNYZ Approved by FDA as First-Line Treatment for Advanced Anal Cancer The FDA approved ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor developed by Incyte, for the treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The approval incl...
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May 19, 2025
7 Emerging Spinal Muscular Atrophy Therapies Offering Hope for Patients
The approval of three spinal muscular atrophy therapies—SPINRAZA (Ionis/Biogen), EVRYSDI (Roche), and the groundbreaking gene therapy ZOLGENSMA (Novartis) has significantly advanced treatment options for a condition that previously had limited solutions. These spinal muscular atrophy (SMA) therapies offer patients ...
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May 16, 2025
J&J Enters gMG Arena with IMAAVY Approval, Challenging AstraZeneca, Argenx, and UCB
The FDA has approved Johnson & Johnson’s anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis (gMG). This myasthenia gravis drug will be marketed under the name IMAAVY. Although J&J isn’t the first to receive FDA approval for an FcRn-blocking antibody in this indication, the c...
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May 15, 2025
Glucotrack Secures Ethical Approval for Extended Clinical Trial of Continuous Blood Glucose Monitor; GE HealthCare Announces FDA Approval for Pediatric Use of Optison and Launches New Ultra-premium 1.5T MRI System; Envoy Medical Advances to Final Stage Following Clinical Milestone; SeaStar Medical Hits Interim Enrollment Goal in NEUTRALIZE-AKI Trial; BD Unveils New Cell Analyzer Integrating Spectral and Real-Time Imaging Innovations
Glucotrack Announced Ethical Approval for Long-Term Clinical Study of Continuous Blood Glucose Monitor On May 13, 2025, Glucotrack, Inc., a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it received ethical app...
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May 14, 2025
Generative AI in Drug Discovery: Applications and Market Impact
The pharmaceutical industry stands at a crossroads, where innovation is no longer a luxury but a necessity. The AI in the drug discovery market is at the forefront of this transformation, driven by the remarkable capabilities of generative AI. This technology, which creates novel solutions by learning from vast dat...
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