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Category: News

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
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 Trials Clinical Data Healthcare & Pharmaceuticals News Vaccines

Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Positive Phase 2 Data

  • By Clinical Trials & Data Desk
  • 20 May 2026
pfizer news

Pfizer has initiated a pivotal Phase 3 study for its 25-valent pediatric pneumococcal vaccine (25vPnC) after Phase 2 data showed a 15-fold increase in immune response against serotype 3.

Tagged Pfizer, Phase 2 Trials, Pneumococcal Vaccine, Vaccine

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AstraZeneca Datroway EU Approval: CHMP Recommends Novel ADC for Metastatic Triple-Negative Breast Cancer
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

AstraZeneca Datroway EU Approval: CHMP Recommends Novel ADC for Metastatic Triple-Negative Breast Cancer

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Regulatory Intelligence Desk
Merck KGaA Acquires Bio-Techne to Advance ProteinSimple and RNAscope Workflows in $11.3 Billion Deal
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BiotechReality Business Intelligence Desk
Pfizer Inc. Announces Milestone as FDA Approves Pfizer’s Ibrance Regimen for Advanced Breast Cancer Frontline Maintenance
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Pfizer Inc. Announces Milestone as FDA Approves Pfizer’s Ibrance Regimen for Advanced Breast Cancer Frontline Maintenance

25 June 202625 June 2026
Regulatory Intelligence Desk
Eli Lilly Completes Acquisition of Centessa Pharmaceuticals to Advance Orexin Receptor 2 Agonist Therapies
Merger & Acquisitions Business Healthcare & Pharmaceuticals News

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BiotechReality Business Intelligence Desk
Gilead Trodelvy European Commission Approval Marks Historic First-Line Breast Cancer Advance
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Gilead Trodelvy European Commission Approval Marks Historic First-Line Breast Cancer Advance

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Regulatory Intelligence Desk
Pfizer Sigvotatug Vedotin Phase 3 Topline Results Released for Lung Cancer
Clinical Data Healthcare & Pharmaceuticals News Oncology

Pfizer Sigvotatug Vedotin Phase 3 Topline Results Released for Lung Cancer

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Clinical Trials & Data Desk
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