May 22, 2025
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
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 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
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
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 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
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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May 13, 2025
Eli Lilly’s ZEPBOUND Outperforms WEGOVY in SURMOUNT-5 Trial Eli Lilly and Company released detailed results from the Phase IIIb SURMOUNT-5 clinical trial, showing that ZEPBOUND (tirzepatide) significantly outperformed WEGOVY (semaglutide) in weight loss among adults with obesity or overweight and at least one we...
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May 12, 2025
Spinal muscular atrophy (SMA) is the second most prevalent autosomal recessive disorder, with a carrier frequency of approximately 1 in 40 to 50 individuals and an estimated occurrence of 1 in 10,000 live births. The majority of SMA cases are caused by the deletion of a portion of the SMN1 gene, which impairs the p...
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May 09, 2025
Congenital Adrenal Hyperplasia (CAH) is a group of inherited genetic disorders that affect adrenal gland function, most commonly caused by a deficiency in the enzyme 21-hydroxylase. This enzyme deficiency disrupts the production of cortisol and often aldosterone, leading to hormonal imbalances and excess androgen p...
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