This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

Federal regulators are telling drugmakers to remove label warnings about potential suicidal thoughts and behaviors from their ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...

Regulators at the U.S. Food and Drug Administration on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity. The ...

Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.

The U.S. Food and Drug Administration (FDA) has granted full approval of Laverdia, a drug to treat dogs with lymphoma, a type ...

The Food and Drug Administration (FDA) recently approved a new generic version of abortion pill mifepristone, a move conservatives are blasting as a “complete betrayal” after Health Secretary Robert F ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

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