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DeepNewz, mobile.
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The US FDA is scrutinizing Geron's drug Imetelstat due to safety concerns, particularly high rates of adverse events. FDA staff also raised safety concerns over CAR-T therapies by Johnson & Johnson and Bristol-Myers Squibb. The FDA is focusing on 'early deaths' in CAR-T trials for myeloma, with discussions planned on the risks and benefits of these treatments.
The @US_FDA introductory comments on Geron's imetelstat going over most of the efficacy and safety questions the agency raised. #odac
Also this ... #Pinksheet #pharma: US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges https://t.co/IdOjBHgx32
For your adcomm reform radar ... #Pinksheet #Pharma: US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’ https://t.co/lizji5lpYu