To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical ...

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

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 guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for ...

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 ...

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 ...

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 ...

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