The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for ...
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.
The fruit puree contained elevated levels of patulin, a naturally occurring substance produced by molds that can grow in ...
PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone in IPF ...
The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...
Months after Trump administration officials hyped a drug as a possible treatment for autism symptoms, one of the largest studies examining its effectiveness in this population has been retracted.
Hims & Hers is facing battles on multiple fronts as it seeks to maintain its lucrative business in copycat weight loss drugs.
Long-term ingestion of patulin can cause immune suppression, nerve damage, headaches, fever and nausea, the FDA says.
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