The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.