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Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk

Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk

Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk
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FDA Grants Priority Review for Pfizer's HYMPAVZI to Address Hemophilia Treatment Needs

FDA Grants Priority Review for Pfizer's HYMPAVZI to Address Hemophilia Treatment Needs

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Pfizer's supplemental Biologics License Application (sBLA) for HYMPAVZI (marstacimab). This review aims to expand the drug's indication to include treatment for hemophilia A or B patients aged 6 years and older with inhibitors, and pediatric patients aged 6 to 11 without inhibitors. Currently, HYMPAVZI is approved for patients 12 years and older with hemophilia A or B without inhibitors. The FDA's decision could make HYMPAVZI the first non-factor prophylactic treatment available for children aged 6 to 11 with hemophilia B. The drug offers a once-weekly subcutaneous injection, providing bleed protection without the need for routine lab monitoring. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for the second quarter of 2026.
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Glioblastoma Patient's Survival Highlights Potential of New Treatment Trial

Glioblastoma Patient's Survival Highlights Potential of New Treatment Trial

Becca Valle, diagnosed with glioblastoma, a typically fatal brain cancer, has survived four years post-diagnosis, defying the odds. Her survival is attributed to participating in a clinical trial at the University of Maryland, which tested a focused ultrasound technique to temporarily open the blood-brain barrier, allowing chemotherapy to penetrate the brain more effectively. The trial showed promising results, with a significant portion of participants surviving longer than expected. The research is ongoing, with hopes of developing an FDA-approved device to enhance treatment options for glioblastoma patients.
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FDA Implements Reforms to Accelerate Cell and Gene Therapy Development

FDA Implements Reforms to Accelerate Cell and Gene Therapy Development

FDA Implements Reforms to Accelerate Cell and Gene Therapy Development
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Cleveland Diagnostics Appoints Jack Kenny as Chairman Amidst IsoPSA Expansion

Cleveland Diagnostics Appoints Jack Kenny as Chairman Amidst IsoPSA Expansion

Cleveland Diagnostics Appoints Jack Kenny as Chairman Amidst IsoPSA Expansion
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Field Medical Unveils Promising Field PULSE Trial Data at AF Symposium

Field Medical Unveils Promising Field PULSE Trial Data at AF Symposium

Field Medical Unveils Promising Field PULSE Trial Data at AF Symposium
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Stanford and Princeton Scientists Launch MedOS to Combat Physician Burnout

Stanford and Princeton Scientists Launch MedOS to Combat Physician Burnout

Stanford and Princeton researchers have introduced MedOS, an AI-XR-cobot system designed to assist clinicians in real clinical environments. This system aims to alleviate physician burnout, which affects over 60% of U.S. doctors, by reducing cognitive overload and minimizing errors through intelligent automation and robotic assistance. MedOS combines smart glasses, robotic arms, and multi-agent AI to function as a real-time co-pilot for medical professionals, enhancing precision care and supporting overburdened clinicians. The system has been tested in surgical simulations and hospital workflows, showing promise in tasks like laparoscopic assistance and treatment planning. MedOS is modular and adaptable, designed to integrate perception, planning, and action, functioning as a clinical co-pilot in high-stakes procedures.
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Co-Diagnostics Joint Venture CoSara Receives License to Manufacture PCR Instrument in India

Co-Diagnostics Joint Venture CoSara Receives License to Manufacture PCR Instrument in India

Co-Diagnostics Joint Venture CoSara Receives License to Manufacture PCR Instrument in India
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FDA Grants Universal Clearance to Bezier Parametric Curve Spinal Rod System

FDA Grants Universal Clearance to Bezier Parametric Curve Spinal Rod System

Spinal Resources, Inc. has achieved a groundbreaking universal clearance for its Bezier Parametric Curve Spinal Rod System, allowing compatibility with any cleared pedicle screw set available in the U.S. market. This clearance, granted by the FDA, marks a significant advancement in spinal surgery technology, providing surgeons with greater flexibility and choice in their clinical decisions. Traditionally, spinal fixation rods are limited to use with pedicle screws from the same manufacturer, restricting surgeon choice and patient benefit. The Bezier Rod system's universal clearance addresses these limitations, offering a biomechanically superior option that enhances patient outcomes. Dr. Saman Shabani, a leading spinal surgeon, highlights the clinical liberty this clearance provides, enabling the use of the best possible technology without manufacturer restrictions.
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Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease
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Biogen forecasts annual profit above estimates as Leqembi sales pick up

Biogen forecasts annual profit above estimates as Leqembi sales pick up

Feb 6 (Reuters) - Biogen forecast 2026 profit above Wall Street estimates on Friday, banking on demand for newer medicines and its Alzheimer's treatment Leqembi as older multiple sclerosis drugs battle pressure from cheaper versions.
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Experimental Pill Enlicitide Shows Promise in Reducing LDL Cholesterol

Experimental Pill Enlicitide Shows Promise in Reducing LDL Cholesterol

A new experimental pill, enlicitide, has demonstrated the ability to reduce LDL cholesterol levels by up to 60% in a phase three clinical trial. The study, published in the New England Journal of Medicine, involved 2,909 patients with atherosclerosis or at risk of developing it. Despite most participants already taking statins, enlicitide significantly lowered their LDL cholesterol levels. The trial was led by Dr. Ann Marie Navar at UT Southwestern Medical Center and sponsored by Merck & Co. Inc. The pill works by binding to PCSK9 in the bloodstream, offering a convenient oral alternative to existing injectable therapies.