In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive care options, covering treatments for acute myeloid leukemia (AML), ...

The 8-page report listed six major observations, concluding that the warehouse was operating outside fundamental Good ...

Apeloa Pharmaceutical, a global provider of technology-driven pharmaceutical manufacturing solutions, has passed its 20th U.S. FDA inspection.

Beta Bionics, Inc. (($BBNX)) has held its Q3 earnings call. Read on for the main highlights of the call. Beta Bionics, Inc. recently held its ...

FDA inspections ensure compliance with GMPs, focusing on documentation practices, SOPs, and non-conformances. Inspections can be surveillance, for-cause, application-based, or follow-up, and occur ...

A Kansas City company is illegally marketing pills that have opioid-like effects and could face possible action, the U.S. Food and Drug Administration wrote in a warning letter sent Tuesday. Shaman ...

FDA inspections are crucial for ensuring compliance in food and pharmaceutical manufacturing, and inspector-specific Form 483 data can provide companies with valuable guidance for achieving regulatory ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

Hyderabad: Pharma player Granules India Ltd on Tuesday informed the bourses that after issuing a Form 483 with six observations for its Gagillapur plant in Hyderabad, the US drug regulator, US Food ...