Sep 19, 2024
Boston Scientific Received FDA Approval For The Expanded Indication of INGEVITY™+ Pacing Leads, Allowing For Conduction System Pacing in The Left Bundle Branch Area On September 17, 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for th...
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Sep 18, 2024
Imagine a world where tiny, lab-grown organs could hold the key to unlocking the mysteries of disease, revolutionizing drug development, and personalizing medicine. Welcome to the fascinating world of organoids—miniature, self-organized clusters of cells that mimic the structure and function of real organs. In rece...
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Sep 17, 2024
TREMFYA Approved for Moderately to Severely Active Ulcerative Colitis Johnson & Johnson announced that the FDA has approved TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA is the first fully human, dual-acting monoclonal antibody that blocks IL-23 and b...
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Sep 16, 2024
A year after failing to meet a trial endpoint, Travere Therapeutics can now relax. On 05 September 2024, the FDA upgraded FILSPARI’s conditional approval for the kidney disease IgA nephropathy to full approval. FILSPARI’s complete approval broadens its use, permitting the small molecule blocker to help slow kidn...
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Sep 13, 2024
Currently, leading hidradenitis suppurativa drugs on the market include UCB Biopharma’s BIMZELX (bimekizumab), Novartis’ COSENTYX (secukinumab), and AbbVie/Eisai’s HUMIRA (adalimumab). HUMIRA dominated the market until 2023, despite its US composition-of-matter patent expiring in December 2016. AbbVie maintained a ...
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Sep 12, 2024
Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...
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Sep 11, 2024
The concept of FemTech has seen a surge in popularity in recent years. FemTech, short for female technology, focuses on using technology and innovation to address women’s health issues and provide solutions tailored to their unique needs. This field encompasses a broad spectrum of diagnostic tools, products, servic...
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Sep 10, 2024
Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...
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Sep 09, 2024
Helicobacter pylori infection is among the most widespread chronic bacterial infections globally, affecting roughly half of the world’s population. H. pylori is classified as a Class I carcinogen by the WHO and is recognized as a qualifying pathogen under the US FDA’s GAIN Act. It is the most significant known risk...
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Sep 06, 2024
Hidradenitis suppurativa is a chronic inflammatory skin disease that affects the hair follicles and apocrine sweat glands. Hidradenitis suppurativa affects approximately 1% of the population, with women being more commonly affected than men. It often begins after puberty, usually in the 20s or 30s. In 2023, the ...
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