All US Food and Drug Administration (FDA) articles
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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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JournalConsiderations for generics developers moving into the field of biosimilars
Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.
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Industry newsIncreased debate over lecanemab
The Lancet has published an editorial encouraging regulators and clinicians to ‘keep an open mind’ about lecanemab, the first drug aimed at slowing the progression of Alzheimer’s disease.
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Industry newsGSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
According to a report by GSK, a recent clinical trial has revealed that Blenrep can reduce the risk of death by 42% in multiple myeloma after relapse.
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Industry newsFDA proposes to remove oral phenylephrine in selected drugs
The US Food and Drug Administration (FDA) has released an update proposing the removal of oral phenylephrine as the active ingredient in drugs for treating nasal congestion.