Tamar Abrams had a lousy couple of years in 2022 and ’23. Both her parents died; a relationship ended; she retired from communications consulting. She moved from Arlington, Virginia, to Warren, Rhode ...
FDA truncates drug approval process; Makary pushes for more OTC drugs; Inside the rocky ride for Recursion Pharmaceuticals.
FDA Commissioner Dr. Marty Makary explains the agency’s decision to lift the warning on hormone replacement therapy and addresses safety and supply concerns.
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...
A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue ...
In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development ...
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...
Even as Novo and U.S. rival Eli Lilly had moved to aggressively cut prices on their GLP-1 weight-loss drugs, Hims announced plans to offer a compounded oral semaglutide pill for $49 - a version of ...
Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...
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