The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...

Bryan O’Donnell, Head of Quality at Gaelic Laboratories, explains how to navigate GMP challenges to ensure your company ...

Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, ...

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.

Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a ...

Amgen's dividend yield remains attractive, with a moderate payout ratio and strong free cash flow. Click here to see why AMGN ...

Pharmaceutical manufacturing encompasses all processes ... Of the 50 different drugs approved by the U.S. Food and Drug Administration (FDA) in 2024, 18 of these agents were biosimilars, eight ...

Pain medication sold at Walmart is being recalled across the country due to an error that could have "fatal" consequences, the FDA says.