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

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

The approval follows late-stage trials showing significant reductions in vomiting versus placebo.

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

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