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FDA accepts sNDA for Cabozantinib for Patients with Advanced Neuroendocrine Tumors

August 13, 2024

FDA grants “Study May Proceed” letter for the Ph 1/2 study of Silmitasertib (CX-4945) + chemo in children and young adults with R/R solid tumors

August 13, 2024

sNDA of Opdivo and Yervoy in Combination Treatment submitted in Japan to Expand the Use for Unresectable HCC

August 13, 2024

PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024

August 7, 2024

FDA Fast Track Designation Granted to Ozuriftamab Vedotin (CAB-ROR2-ADC) for Patients with Recurrent or Metastatic SCCHN

August 7, 2024

Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data

August 6, 2024

IND Application filed for First in Class Senolytic Immunotherapy SenoVax™ for Treatment of Advanced Lung Cancer

August 6, 2024

FDA Clears IND Application for UB-VV111, a CD19 Directed in situ CAR-T for Heme Malignancies

August 6, 2024

FDA Fast Track Designation Granted to Soquelitinib for Treatment of Patients with R/R PTCL

August 6, 2024

FDA grants Orphan Drug Designation for Avutometinib and Defactinib for the Treatment of Pancreatic Cancer

August 6, 2024

FDA Grants Orphan Drug Designation to CLLS52 (alemtuzumab) For ALL Treatment

August 6, 2024

PDUFA Action Date Extension for Revumenib NDA for R/R KMT2Ar Acute Leukemia Announced

July 30, 2024

FDA Advisory Committee reviewed Imfinzi for treatment of resectable NSCLC based on AEGEAN Ph 3 trial results

July 30, 2024

CHMP recommends RYBREVANT + chemo for the treatment of adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy

July 30, 2024

Positive Opinion from CHMP For Toripalimab Announced

July 30, 2024

FDA Accepts BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma

July 30, 2024

FDA Approves Individual Patient IND for Ovarian Cancer CAR-T Therapy

July 30, 2024

FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment

July 30, 2024

Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial

July 30, 2024

Positive feedback received from FDA on the planned TACTI-004 Ph 3 trial of eftilagimod alfa + KEYTRUDA + chemo for the treatment of 1L NSCLC

July 30, 2024

FDA Clears IND for ZW191, a Novel FR-⍺ Targeted Topoisomerase I Inhibitor ADC

July 30, 2024

Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA

July 30, 2024

Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial

July 30, 2024

Positive EU CHMP Opinion for KEYTRUDA + Padcev as 1L Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma

July 30, 2024

DSP-5336 Received FDA Fast Track Designation for the Treatment of R/R AML 

July 23, 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.