The FDA found concerns at a factory in India that makes generic drugs for U.S. patients including one drug that was manufactured at the facility and has been linked to at least eight deaths, ...

The U.S. Food and Drug Administration (FDA) is stepping up testing for heavy metals in infant formula and reviewing key ...

A former commissioner of the Food and Drug Administration says it is vital to invest in ensuring infant formula and breast milk banks are inspected rigorously.

The letter comes after FDA inspections conducted in mid-2024 and late 2024, citing deficiencies in the company's responses to previous observations, according to a Securities and Exchange ...

Autolus has a dedicated commercial manufacturing site in play at Stevenage in the UK, which has already passed an FDA inspection and has the capacity to supply Aucatzyl globally, and has ...

The letter – addressed to Applied's chief executive, Shoshana Shendelman – cites "objectionable conditions" observed in an FDA inspection carried out earlier this year that the regulator ...

I started my tire replacement journey my Shelby Raptor (6 tires) by shopping several of the local tire stores (including Costco). When I spoke with Devin D at the Winchester, VA Pep Boys, he ...

The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines. The letter said the disruption is expected to impact patient care, may ...

In recent days, President Donald Trump has enacted, reversed and paused multiple tariff policies. Most recently, that includes 25% tariffs on Canadian steel imports, which went into effect Wednesday.