News
FDA starts review of AZ's COPD blockbuster hope
The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
News
FDA makes acting CDER, CBER chiefs permanent
Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
News
Pharma body sees 'green shoots' in UK investment
The UK is starting to benefit from a "real partnership" between pharma and government, reversing years of diminishing investment, says the ABPI.
Market Access
The EU Joint Clinical Assessment in practice: Early lessons
Unfortunately, much of the discussion around the JCA has focused on how the framework is intended to operate, rather than how it works in practice.
News
FDA overrides adcomm and approves AZ's oral SERD
The FDA has gone against the advice of its own expert advisors and approved AstraZeneca's Etcamah as a frontline treatment for breast cancer.
News
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