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Otsuka to Present Key Findings from Phase 3 VISIONARY Trial on IgA Nephropathy at GlomCon Hawaii 2026

Otsuka to Present Key Findings from Phase 3 VISIONARY Trial on IgA Nephropathy at GlomCon Hawaii 2026

Otsuka Pharmaceutical Development & Commercialization, Inc. is set to present significant findings from its Phase 3 VISIONARY trial at the GlomCon Hawaii 2026 conference. The trial focuses on VOYXACT® (sibeprenlimab-szsi), a treatment for IgA nephropathy (IgAN), a chronic kidney disease. The study highlights the drug's ability to stabilize estimated glomerular filtration rate (eGFR) over two years, indicating its potential to preserve kidney function and halt disease progression. VOYXACT is the first U.S. FDA-approved selective APRIL inhibitor, targeting the underlying drivers of IgAN. The presentation will include detailed two-year eGFR and safety data, supporting Otsuka's ongoing submission for a supplemental Biologics License Application (sBLA) to the FDA for traditional approval.
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Dasher Neuroscience Completes Enrollment for AI-Driven MSA Drug Trial, Paving Way for New Treatment Options

Dasher Neuroscience Completes Enrollment for AI-Driven MSA Drug Trial, Paving Way for New Treatment Options

Dasher Neuroscience Completes Enrollment for AI-Driven MSA Drug Trial, Paving Way for New Treatment Options
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Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava

Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava

Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava
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FDA Advisers Vote on Peptides for Drug Compounding List, Await Final Decision

FDA Advisers Vote on Peptides for Drug Compounding List, Await Final Decision

FDA advisers have narrowly voted to add six peptides to a drug compounding list, a decision that is non-binding and requires final approval from the FDA. This vote is part of ongoing efforts to regulate and expand the list of substances that can be legally compounded by pharmacies. The decision comes amid growing interest in the use of peptides for various therapeutic purposes, including their potential benefits in treating chronic conditions. The FDA's final decision will determine whether these peptides can be compounded, impacting pharmacies and patients seeking alternative treatment options.
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Recall Issued for AMS Aligned Medical Solutions Kits Due to Lidocaine Contamination

Recall Issued for AMS Aligned Medical Solutions Kits Due to Lidocaine Contamination

Windstone Medical Packaging has initiated a recall of specific Aligned Medical Solutions (AMS) convenience kits due to contamination issues with Elevaris Lidocaine HCl injection USP. The recall affects various medical kits, including Loop Recorder Packs and Biopsy Trays, distributed across the United States. The contamination was identified as a supplier quality issue, prompting the recall to prevent potential risks to patients. The recall notice advises healthcare facilities to quarantine affected products and follow specific procedures to ensure the contaminated Lidocaine is not used.
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Augusta University Study Links Daily Multivitamin to Improved Health in Older Adults

Augusta University Study Links Daily Multivitamin to Improved Health in Older Adults

Augusta University Study Links Daily Multivitamin to Improved Health in Older Adults
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Dasher Neuroscience Completes Enrollment for Phase 2 Trial of AI Drug for MSA

Dasher Neuroscience Completes Enrollment for Phase 2 Trial of AI Drug for MSA

Dasher Neuroscience Completes Enrollment for Phase 2 Trial of AI Drug for MSA
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PRM Pharma and Ingenus Pharmaceuticals Secure Patent for HemiClor Formulation

PRM Pharma and Ingenus Pharmaceuticals Secure Patent for HemiClor Formulation

PRM Pharma and Ingenus Pharmaceuticals Secure Patent for HemiClor Formulation
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The Best Multivitamins for Men Make Daily Nutrition Easier

The Best Multivitamins for Men Make Daily Nutrition Easier

Here’s how multivitamins work to strengthen our immune systems, improve energy, and help us age more gracefully
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FDA's Stance on Single-Country Drug Trials Challenges Biopharma Companies

FDA's Stance on Single-Country Drug Trials Challenges Biopharma Companies

FDA's Stance on Single-Country Drug Trials Challenges Biopharma Companies
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FDA Status and Safety Concerns Surround Semax Use in the U.S.

FDA Status and Safety Concerns Surround Semax Use in the U.S.

Semax, a synthetic peptide developed in Russia, is not FDA-approved for any medical indication in the United States. It is primarily sold as a research chemical, placing it in a regulatory gray area. The FDA has not evaluated Semax for safety or efficacy, and it cannot legally be marketed or sold as a drug or dietary supplement for human use. Most research supporting Semax comes from Russian-language literature, making independent verification challenging for Western researchers. Semax is believed to support focus and cognition through BDNF upregulation, but Western clinical evidence remains limited.
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Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication

Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication

Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication