The Trump administration's mass firings at the U.S. Food and Drug Administration have removed employees critical to reviewing ...
The U.S. Federal Trade Commission's lawsuit against pharmacy benefit managers (PBMs) over insulin pricing practices will ...
Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
Federal efforts that have successfully driven down rates of youth vaping in recent years may be in peril after dramatic ...
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
Eli Lilly is escalating its legal push to protect the exclusivity of its high-profile weight-loss and diabetes drugs, ...
The Hatch Waxman Act and the Biological Price Competition and Innovation Act have incentivized efforts to improperly prolong ...
AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...
Maintaining cold chain compliance is crucial for protecting product integrity, worker safety, and minimizing costs, while ...
Alnylam Pharmaceutical’s has secured US Food and Drug Administration (FDA) approval for Amvuttra (vutrisiran), expanding its use to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare ...
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