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#FDA #Eli Lilly and Company #Johnson&Johnson #Clinical Data #FDA Approval #Cancer #Phase 3 Trials #Novo Nordisk
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 Autoimmune Diseases Healthcare & Pharmaceuticals News

Johnson & Johnson Secures Tremfya FDA Joint Damage Label Expansion for Psoriatic Arthritis

  • By Regulatory Intelligence Desk
  • 29 May 2026
Johnson & Johnson Company Information

The FDA has approved a label expansion for Johnson & Johnson’s TREMFYA® (guselkumab), cementing its position as the first IL-23 inhibitor with data showing it stops the progression of structural joint damage.

Tagged FDA, FDA Approval, Johnson&Johnson, Label Expansion, TREMFYA
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
News Business Healthcare & Pharmaceuticals Merger & Acquisitions

Eli Lilly Anti-Infectious Disease Asset Acquisitions: Strengthening Global Health Solutions

  • By BiotechReality Business Intelligence Desk
  • 26 May 2026
Eli Lilly Updates

Eli Lilly infectious disease acquisitions have officially signaled a new era for Eli Lilly and Company as they aggressively expand their footprint in the anti-infective [Read More…]

Tagged Acquisition, Eli Lilly and Company, Infectious Disease
Clinical Data Healthcare & Pharmaceuticals News

Novo Nordisk’s POSEIDON Study Highlights Global Gap in Managing Cardiovascular Inflammation Risk

  • By Clinical Trials & Data Desk
  • 26 May 2026
novo nordisk

New results from the POSEIDON study presented at the 94th EAS Congress highlight that cardiovascular inflammation risk persists in 40% of high-risk patients, signaling an urgent need for targeted therapies.

Tagged Cardiovascular, Clinical Data, Novo Nordisk, POSEIDON
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 Weight-loss Drugs

Retatrutide Weight Loss Results: Eli Lilly’s Triple Agonist Shows Unprecedented Efficacy

  • By Clinical Trials & Data Desk
  • 21 May 2026
Eli Lilly and Company

Eli Lilly’s Retatrutide has demonstrated record-breaking efficacy in Phase 2 trials, showing that triple-hormone receptor agonists may be the future of chronic weight management.

Tagged Eli Lilly and Company, GLP-1, Phase 2 Trials, Retatrutide

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Clinical Data Healthcare & Pharmaceuticals News Oncology

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Regulatory Approval Healthcare & Pharmaceuticals News Oncology

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