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#FDA #Eli Lilly and Company #Johnson&Johnson #Clinical Data #FDA Approval #Phase 3 Trials #Cancer #Novo Nordisk
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
Biochemistry Life Sciences Science

Amino Acids – Properties, Structure and Classes

  • By Athulya B S
  • 2 April 2025
amino acid structure labeled

Amino acids are chemical compounds that act as the basic building blocks for proteins. They perform vital functions in a variety of biological processes and [Read More…]

Tagged Amino Acids
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
Research Cancer

Recent Cancer Research Shows Treatment Efficacy With Lupus-Related Antibody

  • By Athulya B S
  • 27 March 2025
Recent Cancer Research Shows Treatment Efficacy With Lupus-Related Antibody

Immunotherapies and other cancer treatments don’t work well on “cold” tumors, also known as immunological deserts, because they usually have few T cells.

Tagged Antibodies, Cancer, Cancer Research
Business Clinical Trials Healthcare & Pharmaceuticals News

Bayer and Puhe BioPharma With Global License Agreement For Clinical Phase I PRMT5 Inhibitor for Brain Tumors

  • By Ajmal Aseem
  • 26 March 2025
The Bayer Cross in Leverkusen

For the clinical phase, Bayer has acquired the sole global license for an MTA-cooperative PRMT5 inhibitor that targets MTAP-deleted tumors selectively.

Tagged Bayer, Phase 1 Clinical Trials, PRMT5 Inhibitor

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Samsung Biologics Q3 2026 Results: Plant 5 Ramp-Up and Rockville Lift Revenue to KRW 1,490 Billion as 2026 Guidance Rises to 20%
Business CDMO Healthcare & Pharmaceuticals News

Samsung Biologics Q3 2026 Results: Plant 5 Ramp-Up and Rockville Lift Revenue to KRW 1,490 Billion as 2026 Guidance Rises to 20%

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BiotechReality Business Intelligence Desk
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Clinical Data Healthcare & Pharmaceuticals News

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Clinical Trials & Data Desk
Merck KGaA Announces Silence Therapeutics Acquisition to Add Divesiran siRNA Therapy to Rare Disease Pipeline
Business Healthcare & Pharmaceuticals Merger & Acquisitions News

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BiotechReality Business Intelligence Desk
MSD Oncology Pipeline Advances With First Phase 3 Data for Intismeran Autogene Plus KEYTRUDA and Sacituzumab Tirumotecan
Clinical Data Healthcare & Pharmaceuticals News Oncology

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Clinical Trials & Data Desk
Regeneron Libtayo Dosing Update: CHMP Recommends EU Approval of Every-Six-Week Cemiplimab Regimen Across All Cancer Types
Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Regeneron Libtayo Dosing Update: CHMP Recommends EU Approval of Every-Six-Week Cemiplimab Regimen Across All Cancer Types

16 October 202617 October 2026
Clinical Trials & Data Desk
Lilly Omvoh (mirikizumab-mrkz) Delivers Comprehensive Disease Control in Ulcerative Colitis and Deep Remission in Crohn’s Disease at One Year
Clinical Data Healthcare & Pharmaceuticals News

Lilly Omvoh (mirikizumab-mrkz) Delivers Comprehensive Disease Control in Ulcerative Colitis and Deep Remission in Crohn’s Disease at One Year

15 October 202615 October 2026
Clinical Trials & Data Desk
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