FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
Strategic Repositioning of VB10.16 to Focus on Locally Advanced Cervical Cancer and Recurrent Metastatic Head and Neck Cancer August 27, 2024
FAILED TRIAL: PRECISION1 trial of nab-sirolimus in patients with solid tumors with TSC1/2 inactivating mutations to be halted as study unlikely to exceed the efficacy threshold August 27, 2024
FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies August 27, 2024
RYBREVANT (amivantamab-vmjw) + LAZCLUZE (lazertinib) approved in the U.S. for patients with EGFR-mutated advanced lung cancer August 27, 2024
BerGenBio Collaborates with Tempus to Potentially Accelerate Development in STK11m NSCLC August 27, 2024
Adcendo ApS and Multitude Therapeutics Inc. Announce Global Development and Commercialization Agreement on ADC Drug Candidate Targeting Tissue Factor August 27, 2024
Randomized controlled trial of Nana-val in EBV-positive PTCL patients planned to begin in the second half of 2025 to support potential registration August 27, 2024
First patient dosed in trial of MOMA-313 in patients with cancers carrying mutations in DNA repair genes August 27, 2024
Enrollment Completed in China GC/GEJ Pivotal Ph 2 Clinical Trial of Claudin18.2 CAR T (Satri-cel) August 27, 2024
First Patient dosed in I-SPY 2 Trial Combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- Breast Cancer August 27, 2024
Ph 1a/1b trial of OMX-040 in patients with advanced solid tumors advanced to expansion phase in kidney cancer and angiosarcoma August 27, 2024
First Solid Tumor Patient Treated with Second, Higher Dose in Ph 1/1b BP1001-A Clinical Trial Experienced Tumor Reduction and Continued Stable Disease August 27, 2024
FDA grants Breakthrough Therapy Designation to GSK5764227 for R/R extensive-stage SCLC August 27, 2024
TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC August 27, 2024
Human Research Ethics Committee (HREC) in Australia clears initiation of Ph 1 trial of MNPR-101-Lu August 27, 2024
FDA granted Fast Track Designation to APG-157 for the neoadjuvant treatment of Head and Neck Cancer (HNC) August 27, 2024
EU Approves TEPKINLY® (epcoritamab) for the Treatment of Adults with R/R Follicular Lymphoma August 27, 2024
European Commission approves BALVERSA (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma August 27, 2024
