FDA cites Indiana drug plant for contamination, pest issues, and unresolved equipment failures, raising concerns over pharma manufacturing quality.

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical ...

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost ...

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

The US-EU pharma tariff cap has been finalized at 15%, impacting manufacturing, supply chain, and quality and promoting ...

By 2026, the updates to Chapter 4 and Annex 11, along with the introduction of Annex 22, will bring about a significant ...

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between ...

The company’s commitment to its North Chicago, Ill. plant is part of a previously announced $10 billion capital investment ...

Dave Miller, PhD, discusses how shifting drug manufacturing to domestic CDMOs can improve quality, reduce rework, and enhance ...

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission ...

FDA announced on Aug. 19, 2025 that B. Braun Medical has recalled two lots of its Lactated Ringers Injection, USP, 1000 mL and 0.9% Sodium Chloride Injection, USP, 1000 mL, distributed nationwide up ...