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

Category: News

Regulatory Healthcare & Pharmaceuticals News

U.S. FDA to Phase Out Animal Testing for the Development of Monoclonal Antibodies and Other Drugs

  • By Ajmal Aseem
  • 11 April 2025
US FDA News

The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.

Tagged Animal Testing, Drug Development, FDA, Monoclonal Antibodies
Gene Therapy News Research

Newly Developed Gene Editing Tool Shows Promising Results for Treating Diseases with Multiple Mutations

  • By Athulya B S
  • 10 April 2025
gene editing tool

By inserting a complete gene, the technique provides a one-step solution that overcomes the limitations of CRISPR gene editing technology.

Tagged Gene Editing, Gene Therapy, Mutations
Science Life Sciences News

Dire Wolf Returns After 12000 Years By De-Extinction Technology

  • By Ajmal Aseem
  • 9 April 2025
dire wolf

Colossal Biosciences, the business seeking to make extinction optional, has resurrected a prehistoric predator best known for its role in Game of Thrones. Approximately 20 [Read More…]

Tagged De-Extinction, Dire Wolf
Business Healthcare & Pharmaceuticals News

mAb Capture Made Cost Effective and Productive With Cytiva’s Protein A Resins

  • By Ajmal Aseem
  • 8 April 2025
cytiva resins

A one-size-fits-all strategy to protein purification is no longer practicable, given the development and transformation of the mAb market, notably the recent rapid emergence of [Read More…]

Tagged Cytiva, Monoclonal Antibodies, Protein A Resins
Clinical Trials Anti-obesity Drugs Business Healthcare & Pharmaceuticals News

Ozempic® Results from STRIDE Shown to Improve Walking Distance and Quality of Life in Adults With Type 2 Diabetes and Peripheral Artery Disease (PAD)

  • By Athulya B S
  • 7 April 2025
novo nordisk

Novo Nordisk presented the full results of STRIDE, a phase 3b peripheral artery disease (PAD) outcomes trial that looked at the effects of once-weekly injectable Ozempic®.

Tagged Novo Nordisk, Ozempic
Regulatory Approval Business Healthcare & Pharmaceuticals News

U.S. FDA Approved Amgen’s UPLIZNA® (INEBILIZUMAB-CDON) for the Treatment of Rare Immune Disorder

  • By Athulya B S
  • 6 April 2025
amgen

IgG4-RD can arise in various organs, causing fibrosis and irreversible organ damage. Understanding how organ damage occurs is key to making an accurate diagnosis of IgG4-RD.

Tagged FDA Approval, INEBILIZUMAB-CDON, Rare Immune Disorder
Regulatory Business Healthcare & Pharmaceuticals News

Aldeyra Therapeutics Responds to the U.S. FDA’s Denial of Reproxalap’s NDA Application for Treating Signs and Symptoms of Dry Eye Disease

  • By Ajmal Aseem
  • 3 April 2025
US FDA News

FDA stated in the letter that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes”.

Tagged Aldeyra Therapeutics, FDA, Reproxalap
Regulatory Approval Business Healthcare & Pharmaceuticals News

Pfizer’s RSV Lower Respiratory Tract Disease Vaccine ABRYSVO®Approved by European Commission

  • By Ajmal Aseem
  • 1 April 2025
pfizer news

Pfizer Inc (PFI). announced that the European Commission (EC) has amended the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F [Read More…]

Tagged ABRYSVO, Pfizer, RSV
Healthcare & Pharmaceuticals Business News

Abbott’s Voltâ„¢ Pulsed Field Ablation System Receives CE Mark to Treat Patients with Abnormal Heart Rhythms

  • By Editor's Desk
  • 31 March 2025
abbott

AFib affects around 8 million Europeans over the age of 65, and this figure is anticipated to grow over the next 30 years.

Tagged Abbott, Abbott Volt
Regulatory Approval Business Healthcare & Pharmaceuticals News

U.S. FDA Approved Sanofi’s Qfitlia to Treat Hemophilia

  • By Ajmal Aseem
  • 30 March 2025
sanofi

In order to help hemophiliacs regain hemostasis, Qfitlia helps boost thrombin production by decreasing AT, a protein that prevents blood clotting.

Tagged FDA, FDA Approval, Qfitlia, Sanofi

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Thermo Fisher Scientific Microbiology Business Sale to Astorg Reaches Completion at $1.075 Billion
Merger & Acquisitions Healthcare & Pharmaceuticals News

Thermo Fisher Scientific Microbiology Business Sale to Astorg Reaches Completion at $1.075 Billion

14 August 202614 August 2026
BiotechReality Business Intelligence Desk
Eli Lilly Retatrutide Black Market Draws Six New U.S. Lawsuits From Drugmaker
Legal and Patent Affairs Business Healthcare & Pharmaceuticals News

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

12 August 202614 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
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