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

KEYTRUDA Receives Priority FDA Review for Perioperative Use in ES Head and Neck Cancer

Odronextamab Gains FDA Review for Hard-to-Treat R/R Follicular Lymphoma

FDA Approves Innovative ADC Datroway for Metastatic HR+, HER2- Breast Cancer

FDA Approves Sotorasib and Panitumumab Combo for KRAS G12C+ Colorectal Cancer

FDA Approves 225Ac-SSO110 Radiopharmaceutical Trial for Small Cell Lung Cancer

FDA Grants Priority Review to Datopotamab Deruxtecan for EGFR+ Lung Cancer

First-Ever Obstructive Sleep Apnea Drug, Zepbound, Approved by FDA for Obesity

FDA Approves BRAFTOVI Combo as First-Line Treatment for Colorectal Cancer

FDA Grants Breakthrough Status to Datopotamab Deruxtecan for EGFR+ Lung Cancer

Promising Sac-TMT Receives FDA Breakthrough Therapy Designation for Lung Cancer