BLA submitted for accelerated approval for Telisotuzumab Vedotin (Teliso-V) in Previously Treated NSCLC with c-Met protein overexpression based on Ph 2 LUMINOSITY trial (M14-239) data October 2, 2024
Positive Interim Ph 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma Announced October 1, 2024
Supplemental NDA submitted to FDA for darolutamide + ADT combo in patients with mHSPC October 1, 2024
FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors October 1, 2024
NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis October 1, 2024
Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer September 24, 2024
Blenrep (belantamab mafodotin) combinations in R/R multiple myeloma accepted for regulatory review in Japan September 24, 2024
Blenrep (belantamab mafodotin) combination receives Breakthrough Therapy Designation in China in R/R multiple myeloma September 24, 2024
FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment September 24, 2024
IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI September 24, 2024
FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients Announced September 24, 2024
FDA Approves IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC September 24, 2024
DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma September 24, 2024
Positive EU CHMP Opinions for KEYTRUDA Regimens as Treatment for Patients With cervical cancer and endometrial carcinoma September 24, 2024
