United States Food and Drug Administration
Lilly and J&J Unveil Promising IL-23 Inhibitor Data for Crohn’s Disease, Setting Stage for FDA Decisions
Crohn’s disease, IL-23 inhibitors, Eli Lilly, Johnson & Johnson, Omvoh, Tremfya, clinical trials, FDA decisions.
FDA Approves Iterum’s Orlynvah for Uncomplicated UTIs, Offering New Hope for Patients with Limited Treatment Options
Iterum Therapeutics, Orlynvah, FDA approval, uncomplicated urinary tract infections (uUTIs), oral antibiotic, sulopenem, antimicrobial resistance
Iterum Therapeutics Secures FDA Approval for Orlynvah, Breaking Two-Decade Drought in New UTI Treatments
Iterum Therapeutics, FDA Approval, Orlynvah, Uncomplicated Urinary Tract Infections (uUTIs), Sulopenem Etzadroxil and Probenecid, Oral Penem
Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer
Sacituzumab Govitecan, Trodelvy, Bladder Cancer, Urothelial Cancer, Gilead Sciences, FDA, Accelerated Approval Withdrawal
Medtronic’s Affera System: A Breakthrough in Electrophysiology with FDA Approval for All-in-One Pulsed Field Ablation
Medtronic, Affera, FDA approval, pulsed field ablation, electrophysiology, atrial fibrillation, cardiac ablation
Astellas Secures FDA Approval for Vyloy, a First-in-Class Claudin-Targeted Therapy for Gastric Cancers
Astellas, Vyloy, FDA Approval, Claudin 18.2, Gastric Cancer, Gastroesophageal Junction Cancer, HER2-negative, Zolbetuximab
Fierce Pharma AsiaAstellas’ first-in-class FDA nod; Otsuka’s IgAN win; Samsung Bio’s $1.2B contract
United States Food and Drug Administration, IGA Glomerulonephritis, Sibeprenlimab, Contract agreement, Samsung, first
Pfizer Secures FDA Approval to Expand RSV Vaccine Abrysvo for High-Risk Adults Aged 18-59
Pfizer, RSV vaccine, Abrysvo, FDA approval, high-risk adults, immunocompromised adults
Novo Nordisk Seeks FDA Ban on Compounded Semaglutide Formulations Amid Safety Concerns
Novo Nordisk, FDA, semaglutide, compounding pharmacies, safety concerns, GLP-1 medications, weight loss drugs, diabetes treatments
Sangamo Therapeutics Aligns with FDA on Accelerated Approval Pathway for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, FDA, Accelerated Approval Pathway, ST-920, Fabry Disease, Gene Therapy, BLA Submission