The FDA has issued India's Malladi Drugs & Pharmaceuticals a warning letter and banned its products from the U.S. until it can vastly improve.

The FDA has issued a warning letter to French drug testing lab Quali-Controle, saying some of its testing methods are unvalidated.

Bristol-Myers Squibb will move about 90 manufacturing jobs from its DeWitt, New York, facility to plants in Massachusetts and New Jersey.

Recipharm said the new blow-fill-seal equipment that was part of the company’s $22.3 million investment at its France facility is now operational.

TaiMed Biologics' new HIV med, just approved by the FDA, will be produced by WuXi Biologics in the first Chinese biologics plant approved by the FDA.

Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.

The decision by Lonza to move cell-therapy work out of a U.S. facility that was hit by an FDA warning letter will cost the plant about 125 jobs.

Regeneron says a recent spike in a rare side effect for some Eylea patients is tied to some Becton Dickinson syringes that were distributed in the U.S.