The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

In a warning letter, the Food and Drug Administration said Glenmark Pharmaceuticals failed to properly investigate flaws with a generic drug that ProPublica found was linked to U.S. deaths.

The agency's new drug czar wants to reanalyze risk-benefit data on ingestible fluoride, which is recommended for many ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.

Chief Executive Miranda Toledano said Entera's agreement with the FDA allows Enterea to advance its clinical-development program without having to wait for FDA's qualification of the Study to Advance ...

The 2024 approvals included significant milestones in the biosimilar sector, with the FDA granting approval for the first biosimilar of Stelara, Wezlana and the first denosumab biosimilars, Wyost and ...

Tropicale Foods has recalled a wide range of Helados Mexico and La Michoacana ice cream products due to undeclared milk content. The affected products, distributed nationwide, pose a serious health ...

The clinical-stage biopharmaceutical company said its ateganosine treatment is being evaluated in a phase two clinical trial. If relevant criteria is met during the FDA fast track process, then the ...

Members of an advisory panel have proposed adding warning labels to some medication about adverse maternal and fetal risks in ...

The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps ...

The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.