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The FDA finalized its 2015 guidance on reporting deviations for human cells, tissues and cellular and tissue-based products, also known as HCT/Ps, offering recommendations for complying with federal reporting requirements and listing the most frequent reports received by CBER. Read More
BIO and PhRMA filed a lawsuit challenging Nevada’s new price transparency law for diabetes drugs, arguing it oversteps the state’s authority. Read More
Carlton’s Dunwoody Pharmacy failed to establish a testing program, failed to prepare production records, used inadequate instruments, and violated labeling rules. Read More
A District of Columbia federal court ruled Mylan Pharmaceuticals and two chemical companies must pay $67 million to Blue Cross Blue Shield of Massachusetts and three other insurers in a long-running suit that accused the companies of antitrust violations. Read More
The FDA approved Gazyva for the treatment of patients with follicular lymphoma who relapsed after, or are resistant to, a rituximab-containing regimen. Read More