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Drug Approval

FDA Approval FDA Regulatory Affairs Eli Lilly Trials FDA Fast-Track Approval Therapeutic Goods Administration Surrogate Endpoints NHS Innovations EMA Recommendations Alyftrek and Kaftrio FDA Regulations Efficacy Studies FLOW Trial NHS Treatments Neurology NHS Guidelines Kisqali EMA

NICE Recommends Padcev–Keytruda as First-Line NHS Treatment for Advanced Bladder Cancer

The move follows EV-302 trial evidence showing the combination nearly doubled overall survival versus platinum chemotherapy.

Health Canada Approves Ozempic for Type 2 Diabetes With CKD to Slow Kidney Decline and Reduce Cardiovascular Death

FDA Approves Vizz Eye Drops to Treat Presbyopia

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer

FDA Approves First Systemic Therapy for H3 K27M-Mutant Diffuse Midline Glioma

EMA Recommends Donanemab for Early Alzheimer’s in the EU

NICE Approves Alyftrek, Extending Modulator Treatment to 95% of Cystic Fibrosis Patients

Modified Herpes Virus Plus Nivolumab Induces Tumor Regression in Advanced Melanoma

CDC Panel Recommends Merck’s Enflonsia Monoclonal Antibody for Babies

Triplet Therapy Doubles Survival in BRAF V600E Metastatic Colorectal Cancer

Australia Approves Donanemab as First Disease-Modifying Alzheimer’s Therapy

FDA Approves VYKAT XR, First Therapy for Hyperphagia in Prader-Willi Syndrome

FDA Approves Ozempic to Reduce Kidney Disease Risks in Type 2 Diabetes Patients

FDA Approves Zepbound as First Medication for Obstructive Sleep Apnea in Adults with Obesity

FDA Expands Approval of Kisqali for Early-Stage Breast Cancer