Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.

Sarepta Therapeutics and CDMO Brammer Bio have inked a deal for the production of its microdystrophin Duchenne muscular dystrophy therapy and future gene…

The FDA issued Taiwan Biotech a warning letter, citing a number of issues with the company’s quality-control unit.

After more than two years of intense effort, Sun Pharma has returned its key plant to the good graces of the FDA.

Next stop on WuXi Biologic's rapid advance in biologics manufacturing is the Boston, Massachusetts area where it will build a $60 million facility.

The FDA issued a warning letter to Korean contract drug manufacturer Kolmar Korea, citing significant GMP issues.

The Wasdell Group will invest a half-million pounds in a laboratory project that will support its move into sterile manufacturing this year.

Emergent BioSolutions, which last year picked up a plant from Sanofi that makes smallpox, is now expanding a fill-finish facility.