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Linkedin

Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union

October 25, 2023

COSELA (trilaciclib) Recommended in Updated SCLC Guidelines from the ASCO

October 25, 2023

Global Registrational Ph 3 Study of Lisaftoclax in 1L CLL/SLL Patients Approved by the China CDE

October 25, 2023

FDA Orphan Drug Designation for SLS009 for Treatment of AML

October 16, 2023

Positive EU CHMP Opinion for KEYTRUDA + Chemo as 1L Treatment for HER2-Negative Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)

October 16, 2023

U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma

October 11, 2023

FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

October 11, 2023

FDA grants Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers

October 11, 2023

US FDA grants Orphan Drug Designation for CRO-67

October 11, 2023

FDA Accepts for Priority Review sNDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC

October 11, 2023

Odronextamab BLA for Treatment of R/R Follicular Lymphoma (FL) and DLBCL Accepted for FDA Priority Review

October 3, 2023

FDA clears IND application for Ph 1 study of BC3448

October 3, 2023

Fast Track Designation for IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients with BRCA1/2 Mutations

October 3, 2023

Fast Track Designation for IDE161 for the Treatment of Pretreated, Advanced or Metastatic HR+, HER2-, BRCA1/2 mutant Breast Cancer

October 3, 2023

FDA grants Fast Track Designation to MYTX-011 for Patients with NSCLC with cMET Overexpression

October 3, 2023

FDA Accepts for Priority Review sNDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC

September 26, 2023

IND Clearance from FDA for Ph 1 Initiation for LP-284 in NHL

September 26, 2023

FDA Orphan Drug Designation for Alisertib for the Treatment of SCLC

September 26, 2023

U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma

September 26, 2023

FDA Grants US Orphan Drug Designation to MDX-124

September 26, 2023

FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

September 26, 2023

Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML

September 19, 2023

Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC

September 19, 2023

Positive EU CHMP Opinion for KEYTRUDA as Adjuvant Treatment for Adults with NSCLC at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemo

September 19, 2023

Expedited Development Plan for BT8009 in Metastatic Bladder Cancer Announced

September 19, 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.