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In yet another move toward precision medicine this week, the FDA is mapping out co-development pathways for companion diagnostic devices to accompany targeted therapies. 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
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
The FDA is tweaking its process for designating which center gets jurisdiction over products that defy easy categorization by offering companies a pre-review pathway. Read More