The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination ...

The FDA has approved updated drug labeling for Sandoz in the treatment of B-cell chronic lymphocytic leukemia.

The FDA on Wednesday updated the label for Sandoz's decades-old leukemia drug fludarabine phosphate, as part of a wider ...

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Astellas Pharma's request to update Izervay’s label with two-year data from the GATHER2 trial has been rejected by the FDA ...

Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...

Meanwhile, a frozen cheese pizza usually only needs approval from the FDA once: when the pizza manufacturer adds a ...

Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.

The FDA updated GLP-1 drug labels to warn of the risk of patients breathing food into their lungs while under anesthesia for ...

Two FDA panels were almost unanimous in their opinion that the agency should eliminate restrictions that psychiatrists and ...

If you shop at Walmart, go through your recent purchases. The FDA issued a Class II risk for over 3,600 recalled items.

The FDA has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a ...