As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Industry associations and organizations laud a joint effort by FDA, HHS and USDA to develop a clear, uniform definition of ...

Not all fish are appropriate for sushi - even with creative chefs. Learn which ones to avoid, from texture to toxins, and why ...

The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.

The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD). | The FDA ...

Why Pune's Cafe Goodluck was shut — All you need to know about FDA inspection, glass piece controversy Pune's Cafe Goodluck is in the limelight after its temporarily halted its operations.

WuXi Biologics, a leading global contract research, development and manufacturing organization (CRDMO), announced that five manufacturing facilities successfully passed the Pre-License Inspection (PLI ...

The manufacturing-related rejection also delays a key test of the new FDA leadership’s support for cell and gene therapy against rare diseases.

Q2 2025 Management View CEO David L. Hallal emphasized Scholar Rock is “scaling for the next phase of growth as a commercial stage fully integrated global biopharmaceutical company.” He outlined three ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

WuXi Biologics' pre-filled syringes (PFS) commercial production line passed its first FDA inspection, paving the way for global delivery of high-quality PFS solutions to clients worldwideReinforces ...