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Drug Approval

FDA FDA Approval FDA Regulations Alzheimer's Disease Clinical Trials Lecanemab FDA Approvals Anvisa Cancer Treatment Generic Drugs

FDA Approves Juvmo as First D1/D5 Agonist for Parkinson’s Disease

The drug’s D1/D5 mechanism could slow patients’ need to raise levodopa doses, with U.S. availability scheduled for October 2026.

Overton Dodges Key Science Questions at Senate FDA Hearing

Capricor Faces Multiple Securities Suits After FDA Flags Unapproved Changes to Trial Analysis

FDA Approves Lilly’s Once-Weekly Basal Insulin Onswik for Adults With Type 2 Diabetes

FDA Approves Isembyld, First Muscle‑Directed Therapy for Spinal Muscular Atrophy

FDA Approves Lisraya for Adult Dermatomyositis

FDA Approves Zanvastro as First Treatment for Alexander Disease

FDA Clears Pancreatic Drug That Shows Early Promise in RAS‑Mutant Lung Cancer

FDA Expands Mounjaro Label to Include Cardiovascular Risk Reduction

FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera

FDA Approves First Broad RAS Inhibitor for Metastatic Pancreatic Cancer

FDA Approves Mounjaro to Lower Heart‑Attack and Stroke Risk in High‑Risk Type 2 Diabetes

FDA Approves Rasonque, an Oral KRAS Inhibitor, for Metastatic Pancreatic Cancer

FDA Approves Lisraya as First Oral Treatment for Adult Dermatomyositis

FDA Clears First Broadly RAS‑Targeting Pill for Advanced Pancreatic Cancer

FDA Expands Approval of J&J’s Imaavy to Treat Warm Autoimmune Hemolytic Anemia

HSE Approves Funding for Skyclarys for Friedreich’s Ataxia

Foundayo Oral GLP‑1 Goes On Sale In UK Pharmacies

FDA Approves Regeneron’s Pasatru for Adults With FOP

Anvisa Approves First Brazil-Made Generic Semaglutide and a Similar Product