A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic ...

By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...

Forbes contributors publish independent expert analyses and insights. The U.S. spent $722.5 billion on pharmaceuticals in 2023. Although brand-name drugs consume four out of every 5 dollars America ...

SAN DIEGO, CA, UNITED STATES, May 18, 2026 /EINPresswire.com/ -- Key Takeaways 1.WuXi AppTec's integrated CRDMO ...