April 25, 2025

FDA Approves Penpulimab-kcqx for NPC

The FDA approved penpulimab-kcqx for first line and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Conexiant

April 04, 2025

First IgG4-RD Treatment Approved

A humanized monoclonal antibody that targets CD19+ B cells is first FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.

Conexiant

April 03, 2025

New Option for IgA Nephropathy Management

The FDA has granted accelerated approval to Vanrafia (atrasentan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression.

Conexiant

April 02, 2025

FDA Approves Automated Latent TB Test

Revvity’s Auto-Pure 2400 platform for use with the T-SPOT.TB test to automate latent tuberculosis diagnostics was approved by the FDA.

Conexiant

April 01, 2025

FDA Approves Freeze-Dried Jynneos Vaccine

Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.

Conexiant

March 10, 2025

AI Methods Strengthen Real-World Data Reliability

Researchers assessed the impact of AI-driven methods on real-world data reliability, showing improvements in accuracy, completeness, and traceability

Conexiant

February 24, 2025

Game-Changer for Pfizer? Former FDA Drug Chief Takes Reins

Before leadership at the FDA, Dr. Patrizia Cavazzoni spent nearly 2 decades in the pharmaceutical industry.

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February 19, 2025

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.

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January 28, 2025

FDA Approves Enhertu for Metastatic, HR-Positive, HER2-Low or -Ultralow Breast Cancer

Enhertu, a HER2-directed antibody-drug conjugate, was approved by the U.S. Food and Drug Administration for pretreated patients with metastatic HR-positive, HER2-low or HER2-ultralow breast cancer based on results from the DESTINY-Breast06 trial.

Conexiant