FDA & Government News

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.

Conexiant

February 18, 2025

FDA Clears Aptima SARS-CoV-2 Assay for High-Throughput Testing

FDA grants 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, which uses the Panther system for high-throughput RNA detection.

Conexiant

February 04, 2025

FDA Approves Clinical Trials for Genetically Modified Pig Kidney Transplants

FDA-cleared clinical trials will assess the safety, immunogenicity, and viability of genetically modified pig kidney transplants in patients with end-stage renal disease.

Conexiant

January 29, 2025

Kansas TB Outbreak Grows to 67 Cases

An unprecedented outbreak of Mycobacterium tuberculosis in the Kansas City area has led to the largest recorded cases of TB in recent U.S. history, with significant health implications for the local population.

Reuters

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

Daily News

Stay up to date with the latest clinical headlines and other information tailored to your specialty.

FDA & Government News

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

FDA Clears Aptima SARS-CoV-2 Assay for High-Throughput Testing

FDA Approves Clinical Trials for Genetically Modified Pig Kidney Transplants

Kansas TB Outbreak Grows to 67 Cases

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

Daily News

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