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

Category: Business

Business Healthcare & Pharmaceuticals News

Roche to Invest USD 50 Billion in United States for Pharmaceuticals and Diagnostics Over the Next Five Years

  • By Ajmal Aseem
  • 23 April 2025
Roche

More than 12,000 new jobs will be created by investments, including 1,000 at Roche and more than 11,000 to support the development of new manufacturing capabilities in the US.

Tagged Hoffmann-La Roche, Investment, United States
Healthcare & Pharmaceuticals Business Clinical Investigation News

Pfizer Announces Development Discontinuation of Danuglipron an Oral GLP-1 Receptor Agonist

  • By Ajmal Aseem
  • 14 April 2025
pfizer news

Data from the danuglipron clinical development program will be presented at a scientific meeting or published in a peer-reviewed journal in the future.

Tagged Danuglipron, GLP-1 Receptor, Pfizer
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
Regulatory Business Healthcare & Pharmaceuticals News

Eli Lilly Responds to EMA’s Donanemab Marketing Authorization Rejection

  • By Athulya B S
  • 29 March 2025
Eli Lilly and Company

Eli Lilly and Company’s (LLY) donanemab is not recommended for marketing authorization for the treatment of early symptomatic Alzheimer’s disease, according to an opinion released [Read More…]

Tagged Alzheimer's, Donanemab, Eli Lilly and Company, EMA

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