Type II variation application to EMA submitted for a new indication for CARVYKTI in adult patients with relapsed and lenalidomide-refractory multiple myeloma May 31, 2023
Positive CHMP Opinion to Opdivo + Chemo as Neoadjuvant Treatment of Resectable NSCLC at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression May 31, 2023
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023 May 31, 2023
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma May 18, 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with R/R DLBCL May 10, 2023
POINT Biopharma Announce FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of metastatic CRPC May 10, 2023
FDA grants Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma May 10, 2023
Type A Meeting Request submitted to FDA to Review Proposed Study Design for a Second Ph 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma May 10, 2023
Positive Interim Ph 2 Data for Darovasertib + Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in 1L Metastatic Uveal Melanoma announced May 10, 2023
EMA Validates MAA for Jemperli (dostarlimab) + Chemo for the Treatment of dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer May 10, 2023
Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA April 27, 2023
Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed R/R Multiple Myeloma April 27, 2023
U.S. FDA Accepts for Priority Review Supplemental NDA for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory mCRC April 27, 2023
FDA Accepts Application for KEYTRUDA + Chemo as 1L Treatment for Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma April 20, 2023
IMBRUVICA’s U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications to be voluntarily withdrawn April 12, 2023
mRNA-4157/V940 (mRNA Cancer Vaccine + KEYTRUDA) Receives PRIME Scheme Designation from the EMA for Adjuvant Treatment of Patients with High-Risk Stage III/IV Melanoma Following Complete Resection April 12, 2023
FDA Accepts Supplemental NDAs for BRAFTOVI + MEKTOVI in patients with mNSCLC with a BRAF V600E mutation April 12, 2023
Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory mCRC completed April 6, 2023
Positive CHMP Opinion for Breyanzi for R/R Large B-cell Lymphoma After One Prior Therapy April 6, 2023
