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

Category: Healthcare & Pharmaceuticals

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

Sanofi’s Investigational New Drug Tolebrutinib for Multiple Sclerosis Shows Positive Results in Phase 3 Trials

  • By Athulya B S
  • 13 April 2025
sanofi

Tolebrutinib was generally well tolerated by all subjects across all study arms.

Tagged Investigational Drug, Multiple Sclerosis, Sanofi, Tolebrutinib
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
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
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
Research Vaccines

New Vaccination Concept Targets Dangerous Bacteria in the Intestine

  • By Ajmal Aseem
  • 4 April 2025
new vaccination concept

For a long time, scientists have been looking into vaccines against pathogenic bacteria in the bowel, particularly those that drugs have proved ineffective against due to resistance.

Tagged Bacteria, Vaccination
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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Roche Enspryng MOGAD Filing Wins FDA Priority Review as First Potential Treatment for Rare Neuroimmune Disease
Regulatory Healthcare & Pharmaceuticals News Rare Diseases

Roche Enspryng MOGAD Filing Wins FDA Priority Review as First Potential Treatment for Rare Neuroimmune Disease

10 September 202611 September 2026
Clinical Trials & Data Desk
Charles River Endosafe Cartridge Manufacturing Goes Fully Automated at Massachusetts Facility
CRDMO Business Healthcare & Pharmaceuticals News Technology

Charles River Endosafe Cartridge Manufacturing Goes Fully Automated at Massachusetts Facility

10 September 202610 September 2026
BiotechReality Business Intelligence Desk
Amgen: IMDELLTRA Imfinzi Combination Delivers Landmark Survival Gain in DeLLphi-305 Trial
Clinical Data Healthcare & Pharmaceuticals News Oncology

Amgen: IMDELLTRA Imfinzi Combination Delivers Landmark Survival Gain in DeLLphi-305 Trial

9 September 20269 September 2026
Clinical Trials & Data Desk
Semaglutide Childhood Obesity Trial Meets Primary Endpoint as Novo Nordisk’s STEP Young Study Shows 40.4% of Children No Longer Classified as Having Obesity
Clinical Data Anti-obesity Drugs Healthcare & Pharmaceuticals News Weight-loss Drugs

Semaglutide Childhood Obesity Trial Meets Primary Endpoint as Novo Nordisk’s STEP Young Study Shows 40.4% of Children No Longer Classified as Having Obesity

8 September 20268 September 2026
Clinical Trials & Data Desk
Novartis Pelacarsen Lp(a)HORIZON Trial Results: Phase III Study Misses Primary Cardiovascular Endpoint
Clinical Data Healthcare & Pharmaceuticals News

Novartis Pelacarsen Lp(a)HORIZON Trial Results: Phase III Study Misses Primary Cardiovascular Endpoint

7 September 20268 September 2026
Clinical Trials & Data Desk
IQVIA Predictive Clinical Development Cuts Trial Delays With AI-Powered Approach
Technology Clinical Trials CRO Healthcare & Pharmaceuticals News

IQVIA Predictive Clinical Development Cuts Trial Delays With AI-Powered Approach

6 September 20266 September 2026
BiotechReality Business Intelligence Desk
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