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Drug Approval

FDA Approval Regulatory Affairs FDA Eli Lilly Trials FDA Fast-Track Approval Therapeutic Goods Administration Neurology NHS Innovations Kisqali EMA

CDC Panel Recommends Merck’s Enflonsia Monoclonal Antibody for Babies

Approval by Health Secretary Robert F. Kennedy Jr. is the final step before the FDA-cleared antibody becomes available to infants.

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