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FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies

March 31, 2023

BLA Submission for Lifileucel in Advanced Melanoma completed

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

IND Acceptance by FDA for MT-8421 ETB Program Targeting CTLA-4

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 sBLA 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 mCRPC 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

mRNA-4157/V940 + KEYTRUDA® combo Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients With High-Risk Melanoma Following Complete Resection

February 28, 2023

FDA grants Fast Track designation for KIN-3248 for the treatment of patients with metastatic cholangiocarcinoma

February 22, 2023

Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure

February 22, 2023

China NMPA Clears IND Application for Ph 1/2 Trial of FasTCAR-T GC012F for Treatment of R/R Multiple Myeloma

February 22, 2023

FDA grants Orphan Drug Designation for the PRMT5 inhibitor JBI-778 for the treatment of Glioblastoma Multiforme (GBM)

February 22, 2023

Refusal to File Letter issued from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma

February 22, 2023

FDA Clears IND Application for Ph 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of R/R Multiple Myeloma

February 22, 2023

Orphan Drug Designation Granted to Adze-1.17-CD40L for the treatment of Malignant Glioma

February 22, 2023

US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli as a potential treatment for MMR-D/MSI-high locally advanced rectal cancer

February 22, 2023

FDA Orphan Drug Designation for ezurpimtrostat to treat HCC

February 8, 2023

FDA Approval of IND Application for EP0042 for AML Patients Announced

February 8, 2023

Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome

February 1, 2023

IND cleared for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies

February 1, 2023

FDA clears IND for CLN-978 for the Treatment of R/R B-cell NHL

February 1, 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.