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.
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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.
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Merck rare tumour drug Ezmekly backed for NHS use
Merck's drug for tumours associated with rare disease neurofibromatosis type 1, Ezmekly, has been cleared for NHS use in children as young as two.
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Ionis claims first approval for Alexander disease therapy
Ionis' Zanvastro has been approved by the FDA for Alexander disease, becoming the first disease-modifying therapy for the devastating rare disease.
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FDA issues warning letters to five unapproved GLP-1 websites
In a handful of strongly-worded warning letters, the FDA is cracking down on sales of unapproved peptides - even if they're labelled for research.
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