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.
The plant in India where Biocon makes the biosimilars it shares with Mylan was given a clean bill of health by the FDA last year—but not for long.
Fujifilm will buy biologics operations in Denmark from Biogen as the Japanese company continues to beef up its CDMO business.
A Florida CDMO will build a 40,000-square-foot biomanufacturing facility so that it can handle commercial production for its biopharma clients.
French biotech Cellectis is building facilities in Paris and the U.S. to produce allogeneic CAR-T treatments.
The FDA has again lashed out at a Canadian company that it has been feuding with for years for helping U.S. consumers get drugs on the cheap.
The FDA has issued a warning letter to a Florida CMO that it says has dirty equipment, poor storage methods and questionable record keeping.
Mallinckrodt's BioVectra CDMO, which makes the API for its controversial H.P. Acthar Gel, is expanding and getting some Canadian tax dollars to help.
The FDA has slapped a Teva plant in Florida with a warning letter for issues that have affected the dosing of a schizophrenia drug.