The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...

The company expects next quarter to read out initial data from its Heart-2 trial, which is testing a one-time treatment for people with genetically elevated cholesterol.

Ernst emphasized the strategic transformation of Tivic into a diversified therapeutics company, combining biologic and bioelectronic approaches to address immune dysregulation. This includes ...

While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...

The company has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) — a critical regulatory step. This product is now ready to be converted into a finished drug product.

DevOps and CSV form a powerful duo that, with strategic implementation, promises to propel the pharmaceutical industry.

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

Mr MacGill pleaded not guilty to one count of taking part in the supply of a large commercial quantity of a prohibited drug, with the court told that he claimed he simply introduced the two men ...

Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline.