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Category: News

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
Biosimilars Autoimmune Diseases Healthcare & Pharmaceuticals News

FDA Approves ImmGolis for Accord BioPharma: First Interchangeable Simponi Biosimilar Enters U.S. Market

  • By Regulatory Intelligence Desk
  • 19 May 2026
Accord Biopharma

Accord BioPharma and Bio-Thera Solutions achieve a historic FDA approval for ImmGolis, the first interchangeable simponi biosimilar to reach the U.S. market.

Tagged Accord BioPharma, FDA, FDA Approval

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Legal and Patent Affairs Business Healthcare & Pharmaceuticals News

Eli Lilly Retatrutide Black Market Draws Six New U.S. Lawsuits From Drugmaker

12 August 202613 August 2026
Legal and IP Desk
Novo Nordisk Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available Nationwide in the US
Regulatory Approval Healthcare & Pharmaceuticals News

Novo Nordisk Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available Nationwide in the US

11 August 202612 August 2026
Regulatory Intelligence Desk
Charles River Laboratories Q2 2026 Earnings: Revenue Hits $1.00 Billion as Company Raises Full-Year Guidance
Business CRO Healthcare & Pharmaceuticals News

Charles River Laboratories Q2 2026 Earnings: Revenue Hits $1.00 Billion as Company Raises Full-Year Guidance

8 August 20268 August 2026
BiotechReality Business Intelligence Desk
Moderna mFLUSIVA FDA Approval: Moderna Receives U.S. FDA Approval for Seasonal Influenza Vaccine mFLUSIVA
Regulatory Approval Healthcare & Pharmaceuticals News Vaccines

Moderna mFLUSIVA FDA Approval: Moderna Receives U.S. FDA Approval for Seasonal Influenza Vaccine mFLUSIVA

7 August 20267 August 2026
Regulatory Intelligence Desk
Eli Lilly Q2 2026 Earnings Jump 48% as Mounjaro, Zepbound Fuel Growth; Company Raises Full-Year Guidance
Business Healthcare & Pharmaceuticals News

Eli Lilly Q2 2026 Earnings Jump 48% as Mounjaro, Zepbound Fuel Growth; Company Raises Full-Year Guidance

6 August 20267 August 2026
BiotechReality Business Intelligence Desk
Biocon Q1 FY27 Revenue Rises 10% to Rs 4,336 Crore as Biopharma Business Leads Growth
Business Healthcare & Pharmaceuticals News

Biocon Q1 FY27 Revenue Rises 10% to Rs 4,336 Crore as Biopharma Business Leads Growth

6 August 20266 August 2026
BiotechReality Business Intelligence Desk
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