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Positive Interim Ph 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma Announced

October 1, 2024

FDA cleared IND for Ph 1 clinical study of IPH4502 in solid tumors

October 1, 2024

FDA Clears IND Application for KSQ-004EX eTIL Therapy

October 1, 2024

sNDA submitted to FDA for darolutamide + ADT combo in patients with mHSPC

October 1, 2024

FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors 

October 1, 2024

NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis

October 1, 2024

FDA Fast Track Designation For Narmafotinib In Advanced Pancreatic Cancer

September 24, 2024

Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer

September 24, 2024

Blenrep (belantamab mafodotin) combinations in R/R multiple myeloma accepted for regulatory review in Japan

September 24, 2024

Blenrep (belantamab mafodotin) combination receives Breakthrough Therapy Designation in China in R/R multiple myeloma

September 24, 2024

Positive FDA Meeting and Plans for Dasynoc NDA Resubmission Announced

September 24, 2024

FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment

September 24, 2024

FDA Clearance for Ph 1 Trial of CD-001 Announced

September 24, 2024

US FDA grants CF33-hNIS (VAXINIA) Orphan Drug Designation (ODD)

September 24, 2024

IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI

September 24, 2024

FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients Announced

September 24, 2024

FDA Approves IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC

September 24, 2024

DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma

September 24, 2024

Positive EU CHMP Opinions for KEYTRUDA Regimens as Treatment for Patients With cervical cancer and endometrial carcinoma

September 24, 2024

RMAT Designation from FDA for P-BCMA-ALLO1 to Treat R/R Multiple Myeloma

September 18, 2024

Positive Pre-IND FDA Meeting for Bria-PROS+ for Prostate Cancer Announced

September 18, 2024

FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of MDS

September 17, 2024

FDA Orphan Drug Designation for Elraglusib for Treatment of Soft Tissue Sarcomas

September 17, 2024

Successful pre-BLA meeting with the US FDA to support BLA for RP1 (vusolimogene oderparepvec) in anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024 announced

September 17, 2024

FDA cleared the NCI-sponsored IND application for cirtuvivint

September 17, 2024
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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.