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The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Reblozyl for the treatment of anaemia in adults with beta thalassaemia.
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
The FDA has announced its support of a drug manufacturer rating system that would allow purchasers to identify which have the most reliable supply, in an effort to reduce shortages.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
