The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware ...
DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...
A new antimicrobial generic drug was approved by officials with the FDA for the treatment of canine skin infections: ...
The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...
The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...
The FDA has announced new rules for the approval of biosimilar drug products that could reduce 5- to 8-year timelines by half.
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...