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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 03 December 2020

The FDA is warning of the risk of inadvertent intrathecal administration of tranexamic acid injection, in most cases given accidentally instead of the intended intrathecal anaesthetic. Cartons and...

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Medicines Current Awareness (Remove filter)

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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 04 February 2021

The initial results of a completed safety clinical trial show a higher occurrence of serious heart-related problems and cancer in patients with rheumatoid arthritis treated with tofacitinib (both 5mg...

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Medicines Current Awareness (Remove filter)

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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 12 February 2021

Trilaciclib is a 1st-in-class short-acting CDK4/6 inhibitor which preserves hematopoietic stem cells and enhances immune system function during chemotherapy. Approval was based on three RCTs (n=245) ...

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Medicines Current Awareness (Remove filter)

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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 25 February 2021

Following the submission of supporting data from Pfizer, the US FDA is now permitting undiluted frozen vials of its Covid-19 vaccine to be transported and stored at conventional temperatures commonly...

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Medicines Current Awareness (Remove filter)

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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 25 February 2021

The approval, the first of a targeted treatment for patients with this type of mutation, was based on a placebo-controlled study (n=43) which found those treated with casimersen had a significantly...

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Medicines Current Awareness (Remove filter)

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US Food and Drug Administration - FDA (Remove filter)

Published by US Food and Drug Administration, 27 January 2021

Approval was based on analysis of 39,321 subjects from an ongoing global placebo-controlled RCT (n= 43,783) which found the vaccine was 67% and 66% effective in preventing moderate to severe/critical...

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Medicines Current Awareness (Remove filter)