A separate section on patient-counseling information has been added in response to the requirement that all FDA-approved patient information be reprinted in or accompany drug product labeling.

MARGAO: In a crackdown on substandard food products, the Food and Drugs Administration (FDA) conducted an inspection drive in the Salcete taluka ... that was being transported via bus without proper ...

Jylamvo is an oral liquid formulation of methotrexate originally approved in 2022 for adults with acute lymphoblastic ...

The FDA has approved updated labeling for Flublok (influenza vaccine) to include new safety data involving pregnant individuals.

Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...

The expanded indication in Ph+ CML-CP increases the population eligible for Scemblix by approximately four times, including newly diagnosed and previously treated adults. Newly diagnosed patients will ...

Doctors worry that Medicaid limits on addiction drug dosing could drive some patients back toward the drugs they're trying to ...

Dietary supplements aren't FDA-approved like drugs. The director of the Office of Dietary Supplements offered advice ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Ahead of the upcoming DSCSA November deadline, pharma companies reimagine track-and-trace to tackle the US counterfeit drug ...

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act ...

A fierce rivalry is brewing between gene-editing companies Prime Medicine and Tessera Therapeutics. Jeremy Duffield, Prime’s ...