Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade

Dupixent; chronic spontaneous urticaria (CSU); EU approval; Sanofi; Regeneron; monoclonal antibody; IL-4; IL-13; CUPID phase 3 trials; type 2 inflammation

Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect

Inflation Reduction Act; SCOTUS; drug price negotiation; AstraZeneca; Medicare; pharmaceutical lawsuits; Fifth Amendment; supreme court petition; Farxiga; Centers for Medicare & Medicaid Services; price controls

Novo Nordisk’s Amycretin Significantly Reduces Weight and Blood Sugar in Phase 2 Type 2 Diabetes Trial

Novo Nordisk; Amycretin; Type 2 diabetes; Weight loss; HbA1c reduction; GLP-1 agonist; Amylin receptor agonist; Phase 2 clinical trial; Subcutaneous administration; Oral administration

FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement

FDA; Pazdur; Commissioner’s National Priority Voucher; CNPV; legality; internal disagreement; tumor board; Tidmarsh; drug approval process

FDA Approves Novartis’ Itvisma: Expanding Gene Therapy to Older Spinal Muscular Atrophy Patients

Novartis; FDA approval; Itvisma; Zolgensma; Spinal Muscular Atrophy (SMA); Gene Therapy; Older Children; Adults; Intrathecal Formulation