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Category: Regulatory

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
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
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
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
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
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
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
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

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