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

Category: News

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
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
News Clinical Trials Healthcare & Pharmaceuticals

Gliead Releases the Results of Phase 3 ASCENT-04/KEYNOTE-D19 Trials Shows Positive Effect for Combinational Use of Trodelvy® Plus Keytruda®

  • By Ajmal Aseem
  • 22 April 2025
Gilead

The trial achieved its main goal with a statistically significant and clinically relevant improvement in PFS.

Tagged Gilead Sciences, Keytruda, Merck & Co
Regulatory Approval Healthcare & Pharmaceuticals News

European Commission Approves Roche’s Columvi® (glofitamab) For B-cell Lymphoma Based on the Phase III STARGLO Study Results

  • By Athulya B S
  • 20 April 2025
Roche

Columvi therapy provides a much-needed, off-the-shelf, fixed-duration alternative for transplant ineligible individuals.

Tagged Columvi, glofitamab, Hoffmann-La Roche
Regulatory Approval Healthcare & Pharmaceuticals News

Dupixent (Dupilumab), Sanofi’s New Targeted Therapy For Chronic Spontaneous Urticaria Approved by the U.S. FDA

  • By Ajmal Aseem
  • 19 April 2025
sanofi

Phase 3 tests showing Dupixent dramatically decreased itching and hives when compared to a placebo led to approval.

Tagged Dupilumab, Dupixent, Sanofi
Weight-loss Drugs Clinical Trials Healthcare & Pharmaceuticals News

Eli Lilly’s Orforglipron, an Investigational Oral GLP-1 Weight-loss and Diabetes Pill Shows Similar Efficacy Results of Their Injectable GLP-1

  • By Athulya B S
  • 18 April 2025
Eli Lilly and Company

In a Phase 3 trial, orforglipron, the first small molecule GLP-1, successfully reduced A1C by an average of 1.3% to 1.6% across dosages.

Tagged Diabetes, Eli Lilly and Company, GLP-1, Orforglipron
Regulatory Approval Healthcare & Pharmaceuticals News

European Union Grants Marketing Approval for Biogen’s Leqembi® an Amyloid-beta (Aβ) Monoclonal Antibody

  • By Ajmal Aseem
  • 17 April 2025
biogen

Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.

Tagged Biogen
Clinical Trials Healthcare & Pharmaceuticals News

Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients

  • By Editor's Desk
  • 15 April 2025
eyestem eyecyte rpe

All nine subjects of phase 1 injected without any serious adverse events.

Tagged Eyecyte-RPE, Eyestem, Geographic Atrophy
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
Clinical Trials Healthcare & Pharmaceuticals News

Amgen’s IMDELLTRA® Phase 3 Trials Demonstrated Superior Overall Survival in Small Cell Lung Cancer

  • By Ajmal Aseem
  • 12 April 2025
amgen

IMDELLTRA’s safety profile was consistent with the recognized profile. Detailed DeLLphi-304 results will be presented at an upcoming medical congress.

Tagged Amgen, IMDELLTRA®, Small Cell Lung Cancer

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Thermo Fisher Scientific Microbiology Business Sale to Astorg Reaches Completion at $1.075 Billion
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Legal and Patent Affairs Business Healthcare & Pharmaceuticals News

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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

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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

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

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