Qualitative Concept
UCB’s Bimzelx Receives FDA Approval for Moderate-to-Severe Hidradenitis Suppurativa, Marking Fifth Indication
Bimzelx, Bimekizumab, Hidradenitis Suppurativa, FDA Approval, IL-17A and IL-17F Inhibitor, Chronic Inflammatory Skin Disease
FDA Panel Raises Safety Concerns Over AstraZeneca’s Anticoagulant Reversal Drug Andexxa
AstraZeneca, Andexxa, FDA panel, anticoagulant reversal drug, safety concerns, full approval
Pfizer’s Breakthrough Hemophilia Drug Hympavzi Wins EU Approval
Pfizer, Hympavzi, EU approval, hemophilia A, hemophilia B, marstacimab, once-weekly subcutaneous treatment, pre-filled auto-injector pen
Medtronic Advances Diabetes Management with FDA Clearance of InPen App and Launch of Smart MDI System
Medtronic, FDA clearance, InPen app, Smart MDI system, diabetes management, insulin therapy, continuous glucose monitoring (CGM), Simplera CGM
Citizen Health Secures $14.5M in Seed Funding to Revolutionize Rare Disease Care with AI-Powered Data Platform
Citizen Health, Rare Disease Care, AI-Powered Data Platform, Seed Funding, Chan Zuckerberg Initiative, Personalized Healthcare
Unlocking Health Equity: Leveraging Comprehensive SDOH Market Insights for Enhanced Treatment, Access, and Adherence
Social Determinants of Health (SDOH), Health Equity, Market Insights, Treatment Access, Adherence, Healthcare Outcomes, Data Analytics, Public Health
FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application
FDA, Astellas, IZERVAY, geographic atrophy, age-related macular degeneration, Complete Response Letter, supplemental New Drug Application
Cybin’s Psychedelic Drug CYB003 Demonstrates Sustained Efficacy in Reducing Depression Symptoms Over 12 Months
CYB003, psychedelic drug, depression treatment, sustained efficacy, 12-month symptom reduction, major depressive disorder (MDD), psilocin analog.
Regenxbio Advances Duchenne Muscular Dystrophy Gene Therapy to Pivotal Studies, Potentially Challenging Sarepta’s Dominance
Regenxbio, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), Gene Therapy, RGX-202, Elevidys, Pivotal Studies, Biologics License Application (BLA), FDA Approval
FDA Approves Revuforj, a First-in-Class Menin Inhibitor, for Relapsed or Refractory Acute Leukemia with KMT2A Translocation
FDA approval, Revuforj, Menin inhibitor, Acute leukemia, KMT2A translocation, Relapsed or refractory, Syndax Pharmaceuticals