United States Food and Drug Administration
Kyowa Kirin Invests $330M in Kura’s Leukemia Drug, Gaining Shared Rights Ahead of FDA Submission
Kyowa Kirin, Kura, leukemia drug, FDA submission, pharmaceutical investment
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
FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting
AstraZeneca, Andexxa, FDA, safety concerns, bleeding reversal agent, advisory committee meeting
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
Neurogene Halts Development of Batten Gene Therapy NGN-101 Following FDA Denial
Neurogene, Batten disease, gene therapy, NGN-101, FDA denial, rare disease research
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
Cybin’s Psychedelic Breakthroughs: Advancing Mental Health Treatments
Cybin, psychedelic therapeutics, mental health treatments, deuterated psilocybin, deuterated DMT, clinical trials, FDA Breakthrough Therapy Designation.
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
FDA Approves Danziten: A Breakthrough Nilotinib Treatment for Chronic Myeloid Leukemia Without Mealtime Restrictions
Danziten, Nilotinib, Chronic Myeloid Leukemia (CML), FDA Approval, Mealtime Restrictions, Azurity Pharmaceuticals
Dupixent (Dupilumab) Advances Towards FDA Approval for Chronic Spontaneous Urticaria (CSU) in 2025
Dupixent, Dupilumab, Chronic Spontaneous Urticaria (CSU), FDA Review, Sanofi, Regeneron, Biologic Medicine, Type 2 Inflammation, H1 Antihistamines