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#FDA #Eli Lilly and Company #Johnson&Johnson #Phase 3 Trial #FDA Approval #Clinical Data #Hoffmann-La Roche #Pfizer

Category: Business

Business News

Moderna Reports Q1 2025 Results: Revenue Dips, Focus Shifts to Oncology Amid Expense Cuts

  • By Ajmal Aseem
  • 4 May 2025
moderna

Moderna, Inc. announced its financial results for the first quarter ending March 31, 2025, highlighting a strategic realignment towards oncology and other pipeline candidates amidst [Read More…]

Tagged Moderna, Q1, Quarterly Results
Business News

Eli Lilly Reported a Very Strong Start to 2025, Characterized by Significant Revenue Growth

  • By Athulya B S
  • 1 May 2025
Eli Lilly and Company

Revenue reached $12.73 billion, a substantial 45% increase year-over-year, primarily fueled by strong volume growth from Mounjaro and Zepbound.

Tagged Eli Lilly and Company, Mounjaro, Q1, Quarterly Results, Zepbound
Regulatory Business Medical Devices News

Roche granted FDA breakthrough device designation for VENTANA TROP2, an AI-driven companion diagnostic for non-small cell lung cancer

  • By Athulya B S
  • 29 April 2025
Roche

The gadget analyzes images using artificial intelligence to achieve a degree of diagnosis accuracy that is not achievable with conventional manual grading techniques.

Tagged Hoffmann-La Roche, VENTANA TROP2
Business Healthcare & Pharmaceuticals News

Amgen Announces $900 Million Worth Expansion of Manufacturing Facility in the US

  • By Ajmal Aseem
  • 26 April 2025
amgen

Amgen has made about $5 billion in direct capital investments in the US since the Tax Cuts and Jobs Act of 2017 was passed.

Tagged Amgen, Business Expansion
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

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Editor's Desk
ICOTYDE FDA Approval: J&J’s First-Line Oral Peptide Breakthrough for Plaque Psoriasis Treatment
Regulatory Approval Autoimmune Diseases News

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Atirmociclib Phase 2 Breakthrough: Pfizer Declares Powerful Results for Metastatic Breast Cancer Treatment
Clinical Trials Clinical Data News Oncology

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EBGLYSS (lebrikizumab-lbkz) Delivers Remarkable Phase 3 Results for Pediatric Atopic Dermatitis Treatment
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