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#FDA #Eli Lilly and Company #Johnson&Johnson #Clinical Data #Cancer #Novo Nordisk #FDA Approval #Hoffmann-La Roche

Category: Healthcare & Pharmaceuticals

Clinical Trials Healthcare & Pharmaceuticals News

Data From Phase 3 QUASAR Long-term Extension (LTE) Study Shows TREMFYA® (guselkumab) Maintains Sustained Remission in Ulcerative Colitis

  • By Athulya B S
  • 5 May 2025
JohnsonAndJohnson

Johnson & Johnson today announced significant long-term findings from the Phase 3 QUASAR study program, demonstrating that TREMFYA® (guselkumab) delivered sustained rates of clinical remission [Read More…]

Tagged Guselkumab, Johnson&Johnson, TREMFYA
Clinical Trials Healthcare & Pharmaceuticals News

AstraZeneca Released KALOS and LOGOS Phase III Clinical Trials Result Shows Positive High-level Results of Breztri for Treating Asthma

  • By Athulya B S
  • 2 May 2025
AstraZeneca

The purpose of the duplicate, randomized, double-blind KALOS and LOGOS trials was to examine Breztri as a possible asthma medication.

Tagged Asthma, AstraZeneca, KALOS & LOGOS
Regulatory Approval Healthcare & Pharmaceuticals News

Johnson & Johnson’s IMAAVYâ„¢ (nipocalimab-aahu) Receives U.S. FDA Approval, a Novel FcRn Blocker for Generalized Myasthenia Gravis Patients

  • By Ajmal Aseem
  • 1 May 2025
JohnsonAndJohnson

IMAAVY demonstrated a swift and significant decrease in IgG levels, a primary driver of gMG, in key adult and pediatric trials.

Tagged gMG, IMAAVY, Johnson&Johnson, Myasthenia Gravis
Regulatory Approval Healthcare & Pharmaceuticals News

AbbVie’s RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis

  • By Athulya B S
  • 30 April 2025
AbbVie

Adult GCA can now be treated with RINVOQ (upadacitinib), the first and only oral Janus Kinase (JAK) inhibitor authorized for this purpose.

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
Clinical Trials Healthcare & Pharmaceuticals News

Pfizer released Phase 3 CREST trial results shows reduction of disease-related events in high-risk non-muscle invasive bladder cancer

  • By Ajmal Aseem
  • 29 April 2025
pfizer news

In more than three decades, the first possible therapy breakthrough for BCG-naïve, high-risk non-muscle invasive bladder cancer has been the combination of BCG and sasanlimab, a subcutaneously administered PD-1 inhibitor.

Tagged CREST trial, Pfizer
Clinical Trials Healthcare & Pharmaceuticals News

Abbott Released New Clinical Trial Data Shows Long-Term Benefits of Voltâ„¢ PFA System

  • By Athulya B S
  • 27 April 2025
abbott

In contrast to conventional cardiac ablation techniques, PFA therapy targets specific cardiac tissue regions with high-energy electrical pulses that result in irregular heartbeats.

Tagged Abbott, Abbott Volt, PFA System
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
Clinical Trials Healthcare & Pharmaceuticals News

Roche Released Phase III CENTERSTONE Trial Data Showing Treatment With Xofluza Reduces Influenza Virus Transmission

  • By Ajmal Aseem
  • 25 April 2025
Roche

CENTERSTONE is the first worldwide phase III trial that shows how effective an antiviral medication is at slowing the spread of a respiratory virus.

Tagged CENTERSTONE, Hoffmann-La Roche, Xofluza
Regulatory News

AbbVie Submits Biologics License Application (BLA) to U.S. FDA for TrenibotulinumtoxinE (TrenibotE), Treating Glabellar Lines

  • By Athulya B S
  • 24 April 2025
AbbVie

AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. [Read More…]

Tagged AbbVie, BLA, TrenibotulinumtoxinE

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Clinical Data Diabetes Healthcare & Pharmaceuticals News Weight-loss Drugs

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