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

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

People with an allergy or severe sensitivity to peanuts "may risk serious or life-threatening allergic reactions by consuming ...

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

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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 ...