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Drug Approval

Alzheimer's Disease Alzheimer's Treatment FDA Regulatory Agencies FDA Approval Lecanemab Clinical Trials Attruby Regulatory Affairs Wegovy

FDA Publishes Over 200 Complete Response Letters for 2020–24 Drug Applications

The release aims to demystify the FDA’s review process through transparent feedback redacted for confidentiality.

Eli Lilly’s Oral GLP-1 Pill Matches Injectables in Weight and Blood Sugar Control

FDA Approves Regeneron and Sanofi’s Dupixent for Bullous Pemphigoid

FDA Launches National Priority Voucher Program to Slash Drug Review Times

Arvinas’ Vepdegestrant Delays Breast Cancer Progression Longer Than Faslodex

AI test identifies which prostate cancer patients could halve their death risk with abiraterone

Sotatercept cuts risk of death and hospitalization by 76% in advanced pulmonary arterial hypertension

Three Arrested After Unlicensed Weight-Loss Jab Leaves Woman Hospitalized

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

FDA and CDC Pause Chikungunya Vaccine for Older Adults Over Safety Concerns

New Data Confirms Low Risk of Severe Side Effects for Alzheimer’s Drug Lecanemab

UK Grants First Global Approval for GSK’s Blenrep in Two Combination Therapies

German Court Approves Pharmacist's Production of Unapproved Cancer Drug

Leqembi Approved by European Regulators for Early-Stage Alzheimer's Treatment

EU Approves First Alzheimer's Drug Targeting Disease Progression

EU Commission Approves First Alzheimer’s Therapy Targeting Disease Progression

NICE Approves Capivasertib for NHS Use in Advanced Breast Cancer Treatment

FDA Rejects Aldeyra's Reproxalap NDA for Dry Eye Disease Over Efficacy Issues

EU Regulators Reject Eli Lilly's Alzheimer's Drug Over Safety Concerns

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