Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...

WuXi Biologics ("WuXi Bio"), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the successful completion of the first commercial project Process ...

Under the Medicare Drug Price Negotiation Program, the HHS secretary negotiates directly with manufacturers on the prices ...

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License ...

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene ...

Tensions rise in Korea's pharma sector as Trump plans drug tariffs. Companies like Samsung Biologics monitor the situation ...

Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced the Company has secured multiple market access ...

The Food and Drug Administration is set to rehire some of the staff that was let go during mass firings in the past three months. The rehires will include some food safety inspectors and some ...

Edwards Lifesciences announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic ...

But in the case of human drug reviews by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), Kenned]y’s and Makary’s proposal is ...

manufacturing and warehouse capabilities to enable the launch and commercial production of next-generation biologics and therapies including potent antibody-drug conjugates (ADCs), reinforcing ...