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FDA

Clinical Trials Accelerated Approval Lenacapavir Approval ARS Pharmaceuticals Novo Nordisk Cobenfy Efficacy and Safety Eli Lilly Suzetrigine Public Health GSK New Drug Class Novavax Clinical Investigations Yeztugo Injectable Medications Orforglipron Approval NaV1.8 Inhibitors Aceclidine Approval Precigen Blenrep GLP-1 Medications Combination Therapy Generic Drugs Eydenzelt Breakthrough Therapy Designation DARZALEX FASPRO Blujepa Ziftomenib Biosimilar Approval Mosunetuzumab Brinsupri Medical Devices Kisqali AstraZeneca Regulatory Decisions

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

The one‑minute injection shifts care toward simpler outpatient visits under an approval requiring confirmatory trials.

FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer

FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

FDA Approves Keytruda QLEX, a Rapid Subcutaneous Option for Most Adult Solid Tumor Uses

FDA Approves Papzimeos as First Therapy for Adult Recurrent Respiratory Papillomatosis

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis

Vertex Halts VX-993 Acute Pain Program After Phase 2 Trial Failure