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FDA Approves Belzutifan With Pembrolizumab as Adjuvant Therapy for Clear Cell Kidney Cancer

Regulators cited LITESPARK-022 results showing reduced recurrence risk, with specific dosing and safety guidance issued.

FDA Extends Review of AstraZeneca’s Camizestrant

CHMP Recommends Adding Oral Wegovy Tablets to EU Approval

Sanofi’s Efdoralprin Alfa Beats Standard Therapy in Phase 2 AATD Trial

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

IDEAYA Combo Doubles Progression-Free Survival in Uveal Melanoma Trial

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

Kodiak’s Zenkuda Hits Phase 3 Goal in Diabetic Retinopathy Prompting Faster FDA Filing

FDA Approves First Glucocorticoid Receptor Blocker for Platinum-Resistant Ovarian Cancer

Structure’s Oral Obesity Pill Delivers 16.3% Placebo-Adjusted Weight Loss in Phase 2

Biomea Fusion Reports Positive 52-Week Phase II Results for Icovamenib in Diabetes

FDA Approves Sotyktu for Active Psoriatic Arthritis as First TYK2 Inhibitor

EU Regulators Back First Combined COVID-19 and Flu mRNA Shot for Adults 50 and Over

Anvisa Expands Wegovy and Ozempic Uses to Cardiovascular and Kidney Protection

Sun Pharma Launches Unloxcyt in U.S. for Advanced Cutaneous Squamous Cell Carcinoma

Brazil Approves Twice-Yearly Lenacapavir Injection for HIV Prevention

Brazil Authorizes Leqembi for Early-Stage Alzheimer’s Treatment

FDA Approves First Oral Weight-Loss GLP-1: Wegovy Pill to Launch in January

FDA Clears GSK’s Exdensur as First Twice-Yearly Add-On for Severe Eosinophilic Asthma