Health ❯ Healthcare

Drug Approval

FDA Regulatory Agencies Regulatory Affairs FDA Approval FDA Regulations Clinical Trials Regulatory Bodies European Medicines Agency Accelerated Approval Marketing Authorization Regulatory Review Pharmaceuticals India NICE Recommendations Regulatory Processes Priority Review Marketing Applications Cost-Effectiveness FDA Approvals AI in Healthcare Regulatory Challenges Regulatory Process FDA Processes Health Canada European Commission FDA Approval Process

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 Epkinly Monotherapy and Triplet Regimen 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

J&J Myeloma Trial Stopped Early After Tecvayli–Darzalex Shows PFS and OS Benefit

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

Cannabis Extract VER-01 Eases Chronic Low Back Pain in Phase 3 Trial

Moonlake Shares Plunge on Mixed Phase 3 Results for Hidradenitis Drug

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

European Commission Approves Voranigo for IDH-Mutant Grade 2 Glioma

AstraZeneca’s Fasenra Misses Primary Endpoint in COPD Phase III Trial

Regeneron’s Garetosmab Slashes New Bone Lesions in FOP Phase 3, U.S. Filing Planned This Year

EMA Approves Cardiovascular Indication for Novo Nordisk’s Rybelsus

Jaypirca Delivers Significant PFS Benefit Over Chemoimmunotherapy in First-Line CLL/SLL

European Commission Approves Ogsiveo as First Therapy for Desmoid Tumors

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