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Statement from the FDA on NDMA found in drugs outside the US
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
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FDA’s Center for Drug Evaluation and Research
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FDA approves Aimovig as a preventive treatment for migraines
The FDA has approved Aimovig for the preventive treatment of a migraine in adults. The treatment is given by once-monthly self-injections...
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FDA advances the development of innovative products for OUD
The FDA has announced its latest action to encourage and support the development of treatment options for people with opioid use disorder...
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FDA permits marketing of AI-based device to detect diabetic retinopathy
The FDA has permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy...
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FDA expands approval of Blincyto for treatment of B-cell precursor ALL
The FDA has granted accelerated approval to Blincyto to treat adults and children with B-cell precursor acute lymphoblastic leukaemia (ALL)...
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FDA approves new targeted treatment for acute myeloid leukemia
The U.S. Food and Drug Administration has granted the approval of Idhifa to Celgene Corporation and RealTime IDH2 Assay to Abbott Laboratories...
