Linkedin
RLS logo_header
Linkedin

TOP STORIES from the week

Serplulimab Receives Positive CHMP Opinion for the Treatment of sqNSCLC

Reprogram Biosciences Closes Seed Financing to Advance Tumor Cell Reprogramming Therapeutics

First Patient Dosed in Ph 3 Study of Bulumtatug Fuvedotin in TNBC Patients

FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026

Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

US FDA Approves INQOVI® in Combination with Venetoclax in AML Patients Ineligible for Intensive Induction Chemo

FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

Positive Recommendation from DSMB for Ph 3 Study of Bria-IMT + CPI in Metastatic Breast Cancer

Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

Stay up to date with OTW

Get all oncology clinical development news in your inbox

Drug approvals

Imfinzi approved in the US for patients with BCG-naïve, high-risk NMIBC

European Commission Authorizes Expanded Label for VENCLYXTO® (venetoclax) to Include Additional Combinations in 1L CLL

DARZALEX® (daratumumab) injectable approved for administration by patients or caregivers for treatment of multiple myeloma

Opdivo in Combination with AVD Receives Expanded EU Label with Approval in Frontline Advanced Classical Hodgkin Lymphoma

Regulatory news

Serplulimab Receives Positive CHMP Opinion for the Treatment of sqNSCLC

FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026

FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084) for Certain Patients with 1L Metastatic KRAS G12C-Mutant NSCLC

Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development Successfully Completed

Trial results

Ph 2b Trial of Tebapivat in Lower-Risk Myelodysplastic Syndromes did not meet predefined threshold to support further development 

Primary Endpoints Met in Final Analysis of Ph 3 Study for Perioperative Toripalimab plus Chemotherapy for Resectable Stage II-III NSCLC

Serplulimab Achieves 42.5% pCR Rate in Neoadjuvant Colon Cancer

Ph 3 Trial of Sacituzumab Tirumotecan (sac-TMT) vs Chemo as 1L Treatment for Advanced TNBC Met Primary Endpoint of PFS 

trial status

First Patient Dosed in Ph 3 Study of Bulumtatug Fuvedotin in TNBC Patients

Positive Recommendation from DSMB for Ph 3 Study of Bria-IMT + CPI in Metastatic Breast Cancer

First Patient Dosed in Ph 2 POLKA Study of ART6043 in gBRCAm HER2-Neg Breast Cancer

First Patient Dosed in China for MRCT of pimurutamab (HLX07) Plus serplulimab

Business news

Reprogram Biosciences Closes Seed Financing to Advance Tumor Cell Reprogramming Therapeutics

Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

NETRIS Pharma Secures €7.25M in Horizon Europe Funding to Advance Ph 2b Clinical Trial in Head and Neck Cancer

Adcendo ApS Announces Collaboration with MSD to Evaluate ADCE-T02 in Combination with KEYTRUDA in Ph 1b Study in Patients with Advanced Solid Tumors

Archive

2025

2024

2023

2022

2021

2020

2019

2018