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The FDA hit Eywa Pharma’s Cranbury, N.J., drug manufacturing facility with a three-observation Form 483, citing inadequate investigations of deviations and other quality lapses. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023 following the more than two-year focus on COVID-19, which seriously impacted the center’s operations. Read More
Forty-nine states that are suing more than 20 generic drugmakers over alleged price-fixing can’t force the companies to hand over the profits of their alleged scheme as punishment, a federal judge has determined. Read More
An FDA advisory committee voted unanimously, 13 to 0, on Friday to recommend Bluebird Bio’s investigational gene therapy betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood cell transfusions. Read More