Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...

Drugs meant to reduce the risk of organ rejection may increase the risk of miscarriage and birth defects when taken by female kidney transplant patients, according to a new study. The drugs -- called ...

Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently ...

(Bloomberg) -- The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep under wraps more easily available to investors and the public, ...

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The FDA reduced its therapeutic equivalence rating in Accord Healthcare’s tacrolimus oral capsules because of safety concerns, but the generic’s approval remains, the agency said Sept. 19. Tacrolimus ...

Nearly all U.S. transplant centers require patients to prove they can pay. This story is from Kaiser Health News When Patrick Mannion heard about the Michigan woman denied a heart transplant because ...