BioMérieux is recalling their VITEK 2 AST cards due to a higher concentration of ceftriaxone antibiotic in two wells.

On Tuesday, the agency sent warning letters to 10 pharmaceutical companies threatening legal action for improperly listed patents, and notified the FDA that it disputes the accuracy or relevance of ...

The letter states that Philips failed to ensure its supplier’s validation of the injection molding process for its CT patient interface monitor.

Sen. Bernie Sanders (I-Vt.), chair of the Committee on Health, Education, Labor and Pensions (HELP), has informed Novo Nordisk CEO Lars Fruergaard Jorgensen in a scathing letter that charging ...

U.S. District Judge Zahid Quraishi’s granting of summary judgment against the two drug behemoths squashes their arguments.

From 2020-2021, more than 10 percent of globally manufactured active pharmaceutical ingredients (API) — 147 compounds — were linked to drug shortages in the US, according to a research letter ...

Cardinal did not notify the FDA that it planned to introduce the devices into commercial distribution causing them to be misbranded.

In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final ...

“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of ...

The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT). The feature works by ...