FDA

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FDA reviewer warns of eye trouble with GSK’s myeloma ADC

GlaxoSmithKline heads for an FDA advisory committee meeting this week for belantamab mafodotin – its much-touted treatment for multiple myeloma – with a question about safety h

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FDA grants fast review of AZ's Brilinta to prevent recurring...

The FDA has granted a fast review of AstraZeneca’s cardiovascular diseases drug Brilinta (ticagrelor) in the new indication that aims to reduce the chances of patients having recurring stro

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FDA backs second rare disease drug from Ultragenyx in the sp...

The FDA has approved a second rare disease drug from California-based Ultragenyx in the space of a fortnight, for treatment of long-chain fatty acid oxidation disorders.

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Merck & Co's Keytruda gets new colorectal cancer use after m...

It’s barely a month since Merck & Co unveiled trial results showing that cancer immunotherapy Keytruda (pembrolizumab) works in colorectal cancer patients with certain mutations, and th

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Intercept CEO lays into FDA after NASH drug rejection

Intercept Pharmaceuticals has accused the FDA of moving the goalposts during its review of a potential blockbuster drug for the fatty liver disease known as NASH following a rejection.

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