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Petosemtamab granted Breakthrough Therapy designation by the US FDA for 1L PD-L1 positive head and neck squamous cell carcinoma

February 25, 2025

US FDA grants Fast Track Designation to Cu-67 SAR-bisPSMA for the treatment of metastatic CRPC patients

February 25, 2025

OXC-101 granted ODD status by the FDA in AML

February 25, 2025

FDA grants Fast Track Designation for SIGX1094 for diffuse gastric cancer (DGC)

February 25, 2025

FDA Acceptance and Priority Review of NDA for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma

February 25, 2025

Linvoseltamab BLA Accepted for FDA Review for the Treatment of R/R Multiple Myeloma; PDUFA: 10Jul2025

February 19, 2025

FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer

February 19, 2025

Fast Track Designation granted from the U.S. FDA for Amezalpat to Treat Patients with HCC

February 19, 2025

Orphan Drug Designation granted to OPN-6602 for Multiple Myeloma

February 19, 2025

Positive FDA Guidance Received for Acceleration of Registration-Enabling MIRACLE Trial for R/R AML

February 19, 2025

Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T) for Advanced Ovarian Cancer

February 11, 2025

Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Announced

February 11, 2025

All clinical studies evaluating TIDAL-01 to discontinue and further development of the program halted

February 11, 2025

US FDA Grants Orphan Drug Designation to 225Ac-SSO110 (satoreotide) for the treatment of patients with SCLC

February 11, 2025

Imfinzi recommended for approval in the EU by CHMP for limited-stage SCLC

February 5, 2025

FDA Orphan Drug Designation for MB-105 for T-Cell Lymphoma

February 4, 2025

FDA Rare Pediatric Disease and Orphan Drug Designations for ST-01156

February 4, 2025

FDA feedback provided on potential ELI-002 Ph 3 study design, including dose, schedule, patient population and primary endpoint analysis

January 28, 2025

BLA accepted, Priority Review granted for RP1 for the Treatment of Advanced Melanoma

January 28, 2025

Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of SCLC

January 28, 2025

FDA Clears 225Ac-Satoreotide Ph 1/2 Clinical Study in Patients with SCLC or Merkel Cell Carcinoma

January 21, 2025

NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC

January 21, 2025

NMPA Approves IND for HLX43 in Combination with Serplulimab

January 21, 2025

FDA IND Clearance Receives to Initiate Clinical Testing of R-5780 in Cancer

January 21, 2025

FDA Clearance Received for IND Application of AT03-65

January 21, 2025
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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.