The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

Nigel Langley of gChem stresses excipient innovation, safer solvents, and supply chain resilience for pharma’s future in part ...

AI and accelerated computing are transforming the bio/pharmaceutical sector by addressing organizational, technological, and ...

Some of the most expensive drugs currently in use are gene therapies to treat specific diseases, and their high cost limits ...

Ajinomoto Bio-Pharma Services and Olon S.p.A. have entered into a strategic partnership to deliver drug substance manufacturing services.

UVJC will invest $50 million over the next five years to commercialise its proprietary thin-film printing technology. Read ...

An increasing demand for gene therapies is focusing the industry on enhancing production capabilities, transitioning from ...

Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a ...

This milestone marks the approval of the first product to get U.S. FDA clearance for commercial supply from Kemwell’s Bengaluru drug-product facility since the site became a dedicated biologics campus ...

The agency’s decision to conceal drug names on inspection reports has prevented doctors, pharmacists and patients from ...