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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 Isembyld, First Muscle‑Directed Therapy for Spinal Muscular Atrophy

Isembyld is an IV add‑on to existing SMN2 treatments that showed motor improvement in children and will begin U.S. shipments.

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

FDA Approves Regeneron’s Pasatru for Adults With FOP

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

UK Approves Lilly’s Oral GLP‑1 Pill Foundayo

HSE Drugs Group Recommends Against Funding Skyclarys as Final Vote Looms

UK Regulator Approves Eli Lilly’s Foundayo Tablet for Weight Loss and Type 2 Diabetes

FDA Grants Accelerated Approval for RP1 (Tudriqev) With Nivolumab in Advanced Melanoma

FDA Approves Orzeyful as First Orexin Agonist for Narcolepsy Type 1