FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes and accessories.
AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pert...
The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of key federal science...
Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studies.
A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...
Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...
Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead...
QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Cheetah) based on conce...
