Sep 23, 2024
Better late than never for FDA approval of the first subcutaneous PD-L1 inhibitor—Roche’s TECENTRIQ HYBREZA—after manufacturing delays disrupted the company’s initial launch plans last year. The FDA was originally set to decide on TECENTRIQ’s under-the-skin formulation in September, but Roche’s delivery technolo...
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Sep 20, 2024
Artificial Intelligence (AI) is one of the most groundbreaking innovations of the 21st century, with applications spanning nearly every industry, including healthcare. In respiratory care, Artificial intelligence has the potential to enhance accuracy and efficiency while reducing costs. It can play a transformative...
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Sep 20, 2024
NSCLC is the most common type of lung cancer accounting for approximately 85% of all lung cancers (roughly 509,000 incident cases in 2019 [7MM: the US, EU4 and the UK, and Japan]). The real-world treatment trend depicts a significant shift towards targeted and immunotherapies (from only systemic therapies in the pa...
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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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