Sevabertinib Wins FDA Approval with Strong Responses in HER2-Mutated NSC Lung Cancer

FDA Approves Epcoritamab-bysp as the First Bispecific Antibody for Follicular Lymphoma

FDA Approves Ziftomenib as First Targeted Therapy for NPM1+ Acute Myeloid Leukemia

FDA Approves Libtayo as First Adjuvant Immunotherapy for High-Risk CS Cell Carcinoma

FDA Approves Tecentriq–Zepzelca Combo as FL Maintenance Therapy for ES-SC Lung Cancer

DESTINY-Breast05: Enhertu Outperforms T-DM1 in High-Risk HER2+ Early Breast Cancer

FDA Approves Imlunestrant for ESR1-Mutated Metastatic Breast Cancer

EMA’s CHMP Backs Subcutaneous Pembrolizumab in Head and Neck Cancer

FDA Grants Breakthrough Status to Izalontamab Brengitecan for EGF+ Lung Cancer

The First FDA-Cleared Blood Test for Alzheimer’s Diagnosis Now Available on the Market

FDA Grants Accelerated Approval to Semaglutide for MASH with Liver Fibrosis

FDA Approves Papzimeos, First Immunotherapy for Recurrent Respiratory Papillomatosis

FDA Grants Fast Track Designation to Birelentinib for Relapsed/Refractory CLL and SLL

Zongertinib Gains FDA Accelerated Approval for HER2+ NSCLC with 75% ORR

FDA Approves Modeyso as First-Ever Therapy for Pediatric Brain Tumor, H3 K27M+ Glioma

FDA Fast-Tracks Breyanzi as First CAR T Cell Therapy for Marginal Zone Lymphoma

Novel Viral Immunotherapy SuperNova Gains FDA Fast Track Designation for Sarcoma

EMA Grants Orphan Drug Designation to Nuvisertib for Rare Blood Cancer Myelofibrosis

Imfinzi Receives FDA Priority Review as First Immunotherapy for Gastric and GEJ Cancers

FDA Approves Darolutamide Plus ADT for mCS Prostate Cancer

EU Commission Approves Opdivo Regimen for High-Risk Resectable NSCLC

FDA Approves First Blood Test for Alzheimer’s, Marking a Historic Shift in Early Detection

FDA Approves Emrelis as the First Targeted ADC for High c-Met Expressing Lung Cancer

Avutometinib Earn Accelerated FDA Approval for Ovarian Cancer

FDA Announces AI Strategy with First AI-Assisted Scientific Pilot for Drug Review

Adcentrx’s Nectin-4 ADC, ADRX-0706, Earns FDA Fast Track for Cervical Cancer

First AI-Driven Diagnostic Tool Wins FDA Breakthrough Designation for Lung Cancer

FDA Approves Tislelizumab Plus Chemotherapy for PD-L1+ Metastatic Esophageal Cancer

CHMP Recommends Durvalumab Combination for EU Approval in Resectable NSCLC

Enhertu Gains EMA’s CHMP Support for HER2-Low Metastatic Breast Cancer Treatment