CDMO Thermo Fisher Scientific is investing $150 million to expand biologics and sterile manufacturing at one site in the U.S. and two in Italy.

Lilly plans a $91 million plant expansion in Indianapolis, and a $7 million tax abatement tied to the project has generated some debate.

Spectrum Pharmaceuticals has pulled its biologics license application for Rolontis because the FDA needs more CMC information.

Samsung BioLogics has faced scrutiny of a biosimilars joint venture. Now, officials are looking more closely into the company's 2016 public listing.

Lupin has indicated it has received another FDA warning letter as regulatory issues continue to pile up for the Indian drugmaker.

Merck has served as the sole supplier of an important drug for years, and now the company says it can't quite keep up.

Pfizer is closing a Hospira plant in India, but the FDA still issued a warning letter for a list of serious violations it uncovered last year.

The FDA has approved a new generic of Diovan from India's Alkem to help relieve a shortage of the ubiquitous high blood pressure treatment.