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FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer

September 19, 2023

U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML)

September 14, 2023

MAA submitted to the EMA for Approval of Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations

September 14, 2023

ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers

September 6, 2023

sNDA submitted to FDA for Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma

September 6, 2023

FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

September 6, 2023

sBLA submitted to FDA for RYBREVANT® (amivantamab-vmjw) + Chemotherapy for 1L Treatment of Patients with EGFR Exon 20 Insertion Mutation-Positive mNSCLC

September 6, 2023

sNDA submitted to FDA for Full Approval of BALVERSA for the Treatment of Patients with Locally Advanced/Met Urothelial Carcinoma & Selected FGFR Gene Alterations

September 6, 2023

Application For Lumakras® (Sotorasib) For The Treatment Of KRAS G12C-Positive NSCLC To be Discussed At FDA Advisory Committee Meeting

September 6, 2023

FDA grants Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma

September 6, 2023

Odronextamab Receives EMA Filing Acceptance for Treatment of R/R FL and DLBCL

August 23, 2023

FDA Filing Acceptance and Priority Review for TIBSOVO in the Treatment of IDH1-mutated R/R MDS announced

August 23, 2023

Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial Announced

August 23, 2023

Orphan Drug Designation Granted by the FDA to NXP800 for the Treatment of Cholangiocarcinoma

August 23, 2023

U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation

August 9, 2023

FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R CTCL

August 9, 2023

FDA Orphan Drug Designation granted to Elraglusib for Treatment of Pancreatic Cancer

August 9, 2023

FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma

August 2, 2023

EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies

August 2, 2023

CHMP Positive Opinion for JZP458 for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

August 2, 2023

FDA clears IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma

August 2, 2023

FDA Grants Fast Track Designation to ARX517 for the Treatment of mCRPC

July 27, 2023

Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer

July 27, 2023

FDA grants Fast Track Designation to Selinexor for the Treatment of Myelofibrosis

July 27, 2023

EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation

July 27, 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.