The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined ...

July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...

Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...

From its 17-year development cycle through to its commercial launch, production has always been in Yeztugo’s DNA. And, for the twice-yearly pre-exposure prophylaxis (PrEP) medication—which Gilead ...

The tailor-made comprehensive offering spans a diversified clinical and commercial portfolio of innovative modalities, ...

Demand for GLP-1 drugs such as semaglutide is exposing capacity gaps across peptide APIs, sterile fill-finish facilities, ...

Researchers at Lawrence Livermore National Laboratory (LLNL) have modernized high-explosive (HE) manufacturing by adapting ...