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#FDA #Eli Lilly and Company #Johnson&Johnson #FDA Approval #Clinical Data #Cancer #Quarterly Results #Novo Nordisk

Category: Oncology

Clinical Data Clinical Trials News Oncology

Pfizer LORBRENA CROWN Trial: Record 7-Year Survival Data in NSCLC

  • By Regulatory Intelligence Desk
  • 29 May 2026
pfizer news

Landmark seven-year results from Pfizer’s CROWN study show LORBRENA (lorlatinib) reduces the risk of disease progression or death by 81% in ALK+ NSCLC, setting a new standard for oncology care.

Tagged Clinical Data, LORBRENA CROWN, NSCLC, Pfizer
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

AbbVie Secures its DECNUPAZ FDA Approval for Rare Blood Cancer

  • By Regulatory Intelligence Desk
  • 28 May 2026
AbbVie

AbbVie’s DECNUPAZ FDA approval provides a critical therapeutic lifeline for adult patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This ultra-rare and highly aggressive [Read More…]

Tagged AbbVie, ADC, Antibody Drug Conjugate, Blood Cancer Therapy, Cancer, DECNUPAZ, FDA, FDA Approval
Regulatory Clinical Data Healthcare & Pharmaceuticals News Oncology

AstraZeneca Camizestrant FDA Decision Date Extended: Impact on SERENA-6 Review

  • By Regulatory Intelligence Desk
  • 27 May 2026
AstraZeneca

AstraZeneca has announced a three-month extension to the FDA’s review period for camizestrant, a promising treatment for HR+/HER2- advanced breast cancer with ESR1 mutations.

Tagged AstraZeneca, Camizestrant, Cancer, FDA, NDA
Oncology Business Healthcare & Pharmaceuticals News

GSK Oncology Pipeline: Showcasing Long-Term Outcomes at ASCO and EHA 2026

  • By BiotechReality Business Intelligence Desk
  • 26 May 2026
GSK - GlaxoSmithKline

GSK is set to demonstrate the strength of its oncology pipeline at major 2026 congresses, highlighting long-term outcomes for Jemperli and Blenrep alongside new GIST data.

Tagged ASCO, Cancer, GSK, Pipeline
Regulatory Healthcare & Pharmaceuticals News Oncology

Gilead Secures Positive CHMP Opinion for Trodelvy mTNBC in First-Line Setting

  • By Regulatory Intelligence Desk
  • 23 May 2026
Gilead Sciences Information

Trodelvy mTNBC (sacituzumab govitecan-hziy) has reached a pivotal regulatory milestone in the European Union. On May 22, 2026, Gilead Sciences announced that the Committee for [Read More…]

Tagged Breast Cancer, CHMP, Gilead Sciences, mTNBC, Trodelvy
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

AstraZeneca’s Datroway FDA Approval for TNBC: A New Standard in First-Line Treatment

  • By Regulatory Intelligence Desk
  • 22 May 2026
AstraZeneca

Datroway FDA approval for TNBC was officially granted today, marking a transformative shift in the management of one of the most aggressive forms of breast [Read More…]

Tagged AstraZeneca, Breast Cancer, Datroway, FDA, FDA Approval
Clinical Data Clinical Trials Healthcare & Pharmaceuticals News Oncology

Sacituzumab Tirumotecan Trofuse-005 Trial: Merck (MSD) Hits Primary Endpoints in Advanced NSCLC

  • By Clinical Trials & Data Desk
  • 21 May 2026
Merck MSD

Merck has announced that the Phase 3 Trofuse-005 trial evaluating Sacituzumab Tirumotecan (Sac-TMT) successfully met its primary endpoints, offering a new hope for patients with advanced or metastatic NSCLC.

Tagged Cancer, Clinical Data, Merck & Co, Sacituzumab Tirumotecan
Clinical Data Clinical Trials Healthcare & Pharmaceuticals News Oncology

Novartis New PSMAddition Data: 58% Lower Risk of Pluvicto mHSPC PSA Progression

  • By Regulatory Intelligence Desk
  • 18 May 2026
novartis

Novartis has announced groundbreaking results from the Phase III PSMAddition trial, revealing that Pluvicto significantly reduces the risk of PSA progression by 58% in patients with metastatic hormone-sensitive prostate cancer.

Tagged Cancer, Clinical Data, mHSPC, Novartis, Pluvicto®
Regulatory Approval Clinical Data Healthcare & Pharmaceuticals News Oncology

AstraZeneca’s Enhertu Early Breast Cancer Treatment: FDA Grants Twin Approvals for HER2+ Patients

  • By Regulatory Intelligence Desk
  • 16 May 2026
AstraZeneca

AstraZeneca and Daiichi Sankyo’s Enhertu achieves milestone FDA approvals in two early-stage HER2-positive breast cancer settings, reshaping curative care.

Tagged AstraZeneca, Cancer, Enhertu, FDA, FDA Approval, HER2 Breast Cancer
Clinical Trials Clinical Data Healthcare & Pharmaceuticals News Oncology

Imfinzi EV Bladder Cancer Breakthrough: AstraZeneca Reports Historic Survival Gains in VOLGA Study

  • By Clinical Trials & Data Desk
  • 14 May 2026
AstraZeneca

The Phase III VOLGA trial has reached its primary endpoints, proving that the Imfinzi EV bladder cancer combination delivers historic survival gains in the perioperative setting.

Tagged Bladder Cancer, Clinical Trials Fail, Imfinzi, Phase 3 Trials

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Legal and IP Desk
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