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FDA is warning healthcare providers of faulty filters used in Haemonetics’ Leukotrap RC System that are associated with higher than expected levels of leukocytes in transfused blood. Read More
The UK’s drug pricing watchdog is recommending reimbursement of AstraZeneca’s drug Brilique for patients with a previous history of heart attacks. Read More
In a move that may hinder companies looking to develop generic Tyvaso, the combination product’s developer is asking the FDA to impose stringent approval requirements on generic competitors. Read More
A federal judge has ordered AbbVie to release documents to the Federal Trade Commission related to its marketing of its testosterone treatment AndroGel. Read More
Less than a week after the EMA issued a report on its adaptive pathway, a German agency is taking the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More