Health ❯ Healthcare ❯ Drug Approval

FDA

Clinical Trials Lenacapavir Approval ARS Pharmaceuticals GLP-1 Medications Novo Nordisk Accelerated Approval Eli Lilly Blujepa Medication Efficacy Eydenzelt

FDA Grants Accelerated Approval to Sonrotoclax for Relapsed Mantle Cell Lymphoma

The move offers patients who failed BTK inhibitor therapy a new BCL2 option with early signs of durable response.

Single CAR T Infusion Clears Residual Disease in High-Risk Smoldering Myeloma Trial

GSK Gains After Cramer Endorsement as Company Pushes Into Weight-Loss Drugs

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

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

FDA Approves Komzifti, First Menin Inhibitor for Relapsed NPM1‑Mutant AML

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 Lilly’s Inluriyo for ESR1‑Mutated Advanced Breast Cancer

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

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer

FDA Approves First Systemic Therapy for H3 K27M-Mutant Diffuse Midline Glioma

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

BMJ Reveals Data Flaws in Pivotal Ticagrelor FDA Approval Studies

FDA Demands New Trials for Novavax COVID Vaccine, Raising Concerns Over Fall Booster Rollouts

FDA Approves First New Oral Antibiotic for UTIs in Nearly 30 Years