Just a month after FDA staff gave a ringing endorsement to Pfizer's biosimilar for Amgen's blockbuster Epogen, the agency rejected the drug.

Bristol-Myers Squibb will unload an API plant in Ireland to a South Korean company with large aspirations in contract manufacturing.

The European Union this week posted regulations that upon the U.K.’s exit for the EU its API makers will be treated like those from China and India.

Particle Sciences will have commercial manufacturing capabilities operating at its Pennsylvania facility by the end of the year and will add 30 jobs.

Albany-New York based AMRI has agreed to a buyout worth more than $920 million as the M&A market for contract manufacturers continues to run hot.

CordenPharma has joined the small but growing cadre of pharma companies adding continuous manufacturing to their mix of manufacturing operations.

Lonza, which is dealing with FDA concerns about its cell manufacturing facility in the U.S., has acquired a gene and cell CMO in Europe.

Roche has recalled all of its 5-mg Valium blister packs in Australia after uncovering a supply chain breach at a distributor's warehouse.