Mar 05, 2025
Major Depressive Disorder (MDD) is a widespread and debilitating psychiatric condition that continues to challenge patients, caregivers, and healthcare systems worldwide. Characterized by persistent sadness, loss of interest, cognitive dysfunction, and suicidal ideation, MDD remains a major public health concern. D...
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Mar 04, 2025
FDA Grants Priority Review to Precigen’s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec†), an investigational AdenoVerse gene therapy for adults with recurrent respiratory pa...
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Mar 03, 2025
Ono Pharmaceuticals received FDA approval on 14 February 2025 for vimseltinib, a treatment for tenosynovial giant cell tumor (TGCT), which will be sold under the brand name ROMVIMZA. This approval positions Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT market. ...
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Feb 28, 2025
The Major Depressive Disorder drug treatment market is expanding rapidly due to the increasing demand for antidepressants and the disease’s profound impact on quality of life. In 2023, the major depressive disorder market across the 7MM was valued at an impressive USD 7.2 billion, and it’s poised for even greater e...
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Feb 27, 2025
Medtronic Earned U.S. FDA Approval for the World's First Adaptive Deep Brain Stimulation System for People With Parkinson's On February 24, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for BrainSense™ Adaptive...
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Feb 26, 2025
Alzheimer’s disease remains one of the most complex and devastating neurodegenerative disorders, affecting millions worldwide and placing an immense burden on patients, caregivers, and healthcare systems. Characterized by progressive cognitive decline, memory loss, and functional impairment, Alzheimer’s disease cur...
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Feb 25, 2025
FDA Approves CTEXLI, the First-Ever Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disorder Mirum Pharmaceuticals, Inc. announced that the FDA has approved CTEXLI (chenodiol) tablets as the first and only treatment for cerebrotendinous xanthomatosis (CTX), a rare, progressive, and debilitatin...
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Feb 24, 2025
Parkinson’s disease, a progressive neurodegenerative disorder, is emerging as a significant health challenge in the United States and globally, primarily due to an aging population. This condition, characterized by motor symptoms such as tremors, muscle rigidity, and slowed movement, along with numerous non-motor s...
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Feb 21, 2025
Johnson & Johnson’s SPRAVATO, which is already on track to become a blockbuster drug, has received a significant boost with the FDA’s approval for its use as a standalone treatment for major depressive disorder (MDD). Initially approved in 2019, SPRAVATO was authorized for use alongside an oral antidepressant i...
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Feb 20, 2025
Neonav® ECG Tip Location System Received FDA 510(k) Clearance to Improve Pediatric Vascular Access Care On February 16, 2025, Navi Medical Technologies, a leader in pediatric healthcare innovation, announced that its Neonav® ECG Tip Location System received 510(k) clearance from the U.S. Food and Drug Admi...
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