CHMP Adopts Positive Opinion Recommending Approval of Opdivo in Combination with Cisplatin and Gemcitabine for the 1L Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma May 1, 2024
Ph 2/3 pivotal trial design and protocol for HB-200 + Keytruda in 1L HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC) aligned with FDA feedback May 1, 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer May 1, 2024
CARVYKTI (ciltacabtagene autoleucel) Approved by the European Commission for 2L Treatment of Patients with R/R Multiple Myeloma May 1, 2024
Vebreltinib approved in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene May 1, 2024
FDA approves Lutathera® for pediatric patients with gastroenteropancreatic neuroendocrine tumors May 1, 2024
OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for R/R BRAF-altered Pediatric Low-Grade Glioma (pLGG) May 1, 2024
XTANDI (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting May 1, 2024