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According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...
1d
SurvivorNet on MSNFDA Loosens Safety Requirements For CAR T-Cell Therapies, Paving The Way For Many More Blood Cancer Patients To Access Innovative TreatmentThe FDA has loosened safety restrictions for six CAR T-cell immunotherapies, used in treating a number of blood cancers.
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
This is what it looks like when disinformation doctors pretend to value data and science to further their true objective, ...
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...
The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...
Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...
The nascent leadership team assembled by Kennedy consists of highly talented and respected experts in their fields. Let’s ...
Major health groups sue HHS and Robert F. Kennedy Jr. over COVID-19 vaccine policy changes for children and pregnant ...
Jeneen Interlandi, a domestic correspondent for Opinion and a staff writer at the magazine, writes frequently about public ...
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