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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

EMA validated Type II Application for Opdivo plus Yervoy for 1L Treatment of Unresectable or Advanced HCC

July 23, 2024

sNDA accepted for Toripalimab Combined with Bevacizumab for the 1L Treatment of Advanced HCC

July 23, 2024

FDA Fast Track Designation for Pancreatic Cancer Dendritic Cell Vaccine

July 23, 2024

U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric AML

July 23, 2024

End-of-Phase-2 Meeting Outcomes and Topline Interim Ph 2 Data for BOT/BAL in MSS Colorectal Cancer announced

July 23, 2024

FDA Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma

July 17, 2024

IND Submission to US FDA for Ph 1/2 study of Silmitasertib (CX-4945) in children and young adults with R/R solid tumors

July 17, 2024

505(b)(2) NDA for Lutetium Lu 177 Dotatate Injection submitted to the FDA for the treatment of somatostatin receptor-positive GEP-NETS

July 17, 2024

EMA Orphan Drug Designation for SLS009 for the Treatment of AML

July 17, 2024

FDA Fast Track Designation for ADI-270 in Metastatic/Advanced Clear Cell RCC

July 17, 2024

US FDA grants IND Clearance to Conduct Ph 1/2 Study of JCXH-211 IV as Monotherapy and with Checkpoint Inhibitor in Patients with Advanced Solid Tumors

July 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.