The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.

Welcome to our live blog tracking the latest news and developments from the United States. Stay updated with real-time ...

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

HealthDay News — More than 100,000 Rich’s Ice Cream Co. bars have been recalled due to possible listeria contamination. The affected ice cream bars were sold across 23 states and in Nassau, capital of ...

Surgery, a unit of Johnson & Johnson , issued a correction for certain lots of a part related to its surgical stapler and ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

Key Takeaways Keurig K-cups are being recalled due to a packaging issue The concern is that ink may run into the coffee ...

The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...