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U.S. IND for the Phase I Trial of ATG-031 announced

May 31, 2023

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

FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer

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

FDA Accepts BLA of Lifileucel for the Treatment of Advanced Melanoma

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 mCRPC

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

Update on FDA Advisory Committee vote on Lynparza plus abiraterone for mCRPC

May 10, 2023

Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer

April 27, 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 sNDA 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 sNDAs for BRAFTOVI + MEKTOVI in patients with mNSCLC with a BRAF V600E mutation

April 12, 2023

BLA Submission for Lifileucel in Advanced Melanoma completed

April 6, 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
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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.