Mar 12, 2025
Obesity is the second leading cause of preventable death and is linked to numerous inflammatory conditions, which contribute to diseases like cardiovascular disease, diabetes, respiratory issues, mental health disorders, hypertension, obstructive sleep apnea, cancer, and high cholesterol. This poses a significant p...
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Aug 20, 2024
Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (...
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Aug 19, 2024
The first horse bearing Novartis’ IgAN treatment has reached the FDA’s approval milestone. FABHALTA is approved for use in treating IgAN patients who are at risk of swift disease progression, as evidenced by a urine protein-to-creatinine ratio of 1.5 g/g or higher. On August 8, the FDA approved the use of Novart...
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Aug 15, 2024
The Masimo W1® Medical Watch Secured FDA 510(K) Clearance for its Connectivity with the Masimo Safetynet® Telemonitoring System On August 12, 2024, Masimo announced that its Masimo W1® medical watch received FDA 510(k) clearance for connectivity. This approval enabled the watch to integrate with the Masimo...
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Aug 16, 2024
A year after rejecting it, the FDA has now approved Ascendis Pharma’s once-daily injectable YORVIPATH for hypoparathyroidism treatment. Ascendis Pharma’s YORVIPATH (palopegteriparatide), formerly called TransCon PTH, has been approved for the treatment of adults with hypoparathyroidism. This rare condition, charact...
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Aug 14, 2024
Herpes Simplex Virus (HSV)-associated oncolytic virus therapeutics are a promising approach to cancer treatment. These treatments use genetically engineered HSV to target and destroy cancer cells while preserving healthy tissue specifically. The HSV is designed to increase selectively within tumor cells, causing th...
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Aug 13, 2024
Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency Ascendis Pharma A/S has announced that the FDA has approved YORVIPATH (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. YORVIPATH, a prodrug of parathyroid hormone (PTH[1-34]), is adm...
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Aug 12, 2024
Adaptimmune Therapeutics and patients waiting for synovial sarcoma treatment witnessed a historic moment at the start of this month. After over ten years without new synovial sarcoma treatments, a groundbreaking, first-in-class cell therapy, TECELRA (afamitresgene autoleucel) has been approved by the FDA. This a...
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May 12, 2025
The pharmaceutical industry is witnessing a seismic shift, fueled by the meteoric rise of GLP-1 agonist molecules. Once a niche class of diabetes drugs, GLP-1 agonists have become the cornerstone of a global race to conquer obesity, a disease that has more than doubled in prevalence since 1990 and now affects over ...
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Aug 08, 2024
MIMEDX Announced the Launch of HELIOGENTM Fibrillar Collagen Matrix On July 31, 2024, MiMedx Group, Inc. launched HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product designed to treat complex wounds, especially in surgical environments. HELIOGEN is a shelf-stable product that contains Type...
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