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U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications to be voluntarily withdrawn April 12, 2023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
FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies March 31, 2023
QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 March 31, 2023
FDA Advisory Committee Votes In Favour of the Clinical Benefit of Polivy Combination For People With 1L DLBCL March 15, 2023
FDA Orphan Drug Designation Granted to Batiraxcept for the Treatment of Pancreatic Cancer March 15, 2023
FDA Clearance of IND Application for Phase 1/2 Clinical Trial (Starlight-1) of EB103, a CD19-Targeted ARTEMIS® T Cell Therapy, to Patients with B-Cell Lymphomas March 15, 2023
Libtayo® (Cemiplimab) + Chemotherapy combo Receives Positive CHMP Opinion For The Treatment Of Advanced PD-L1 Positive NSCLC March 15, 2023
FDA accepts Supplemental BLA and EMA Validates Application for Opdivo as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma March 15, 2023
Update provided on US Regulatory Review of LYNPARZA + Abiraterone in metastatic CRPC patients March 15, 2023
Elranatamab Receives FDA and EMA Filing Acceptance with Submissions based on favorable MagnetisMM-3 trial results in patients with R/R multiple myeloma February 28, 2023
