Qualitative Concept
GE HealthCare’s Flyrcado (flurpiridaz F 18) PET Radiotracer Receives FDA Approval for Enhanced Detection of Coronary Artery Disease
GE HealthCare, Flyrcado, flurpiridaz F 18, PET radiotracer, Coronary artery disease (CAD), FDA approval, Cardiac imaging, Nuclear cardiology
FDA Tracker: Fresenius Kabi and Formycon’s Stelara Biosimilar Set for 2025 Launch
Stelara biosimilar, Fresenius Kabi, Formycon, FDA approval, ustekinumab, Johnson & Johnson, J&J settlements, biosimilar competition
UK Regulator Approves Pharming’s Joenja for Rare Immune Disorder APDS, Leveraging FDA Review
Joenja, leniolisib, APDS, MHRA approval, FDA review, rare immune disorder, Pharming
Bristol Myers Squibb’s $14 Billion Bet Pays Off: FDA Approves Novel Schizophrenia Drug Cobenfy
Bristol Myers Squibb, Karuna Therapeutics, FDA approval, schizophrenia, Cobenfy, novel treatment, muscarinic receptor, psychiatric medication
Sanofi and Regeneron’s Dupixent Secures Historic FDA Approval as First Biologic Treatment for COPD
Dupixent, COPD, FDA Approval, Biologic Treatment, Sanofi, Regeneron
Pfizer Withdraws Sickle Cell Disease Treatment Oxbryta Globally Due to Safety Concerns
Pfizer, Oxbryta, sickle cell disease, global market withdrawal, safety concerns, clinical trials, vaso-occlusive crises, fatal events
FDA Approves IntraBio’s Aqneursa for Niemann-Pick Disease Type C, Marking Second Approval in a Week
IntraBio, Aqneursa, Niemann-Pick disease type C, FDA approval, rare neurodegenerative disease, levacetylleucine
Headlands Research Expands with New Clinical Trial Site in El Paso, Texas
Headlands Research, clinical trial site, El Paso, Texas, diversity in clinical research, clinical trials, medical research
Astellas’ Vyloy (Zolbetuximab) Receives EU Approval for Advanced Gastric and Gastroesophageal Junction Cancer Treatment
Astellas, Vyloy, Zolbetuximab, EU Approval, Gastric Cancer, Gastroesophageal Junction Cancer, Claudin 18.2, Targeted Therapy
FDA Approves Bimzelx for Expanded Indications: Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
Bimzelx, FDA approval, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, IL-17A and IL-17F inhibitor