FDA Breakthrough Therapy Designation granted to Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) June 10, 2025
FDA Orphan Drug Designation granted to MVdeltaC for the treatment of pleural mesothelioma June 10, 2025
Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant NSCLC June 3, 2025
Patritumab Deruxtecan BLA for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC Voluntarily Withdrawn June 3, 2025
FDA clears IND application for ERAS-4001 for the treatment of patients with KRAS-mutant (KRASm) solid tumors June 3, 2025
FDA Accepts and grants Priority Review of NDA for Ziftomenib in Adults with R/R NPM1-Mutant AML June 3, 2025
FDA grants Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the Treatment of Prostate Cancer June 3, 2025
Imfinzi recommended for approval in the EU by CHMP as perioperative immunotherapy for MIBC June 3, 2025
MAA submitted to the EMA for Zepzelca® (lurbinectedin) + Tecentriq for the maintenance treatment of adult patients with ES-SCLC May 27, 2025
CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer May 27, 2025
FDA ODAC votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma May 27, 2025
NMPA CDE grants Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC May 27, 2025
Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with R/R B-ALL May 27, 2025
FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC May 27, 2025
FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab + Chemo for Patients With R/R DLBCL May 27, 2025
EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients May 21, 2025
U.S. FDA granted Fast Track Designation for ZL-1310 for Treatment of Extensive-Stage SCLC May 21, 2025
IND application for Ph 1 trial of Penetrium™ in combination with docetaxel voluntary withdrawn May 21, 2025
