The U.S. Food and Drug Administration (FDA) has issued new draft guidance that mandates the inclusion of overall survival (OS) data in all randomized clinical trials...
The U.S. Food and Drug Administration (FDA) has issued new draft guidance requiring that overall survival (OS) data be included in all randomized cancer drug clinical...
Sarepta Therapeutics has successfully completed a debt refinancing deal, allowing the biotechnology firm to restructure its financial obligations. This move comes amidst ongoing challenges with the...
Sarepta Therapeutics has successfully refinanced its debt, providing the biotech firm with a stronger financial footing as it navigates a complex regulatory landscape. This move comes...
Neurizon Therapeutics has announced a delay in the decision regarding its Investigational New Drug (IND) application, attributing the setback to “strain” within the U.S. Food and...
The U.S. Food and Drug Administration (FDA) has announced the launch of the new “FDA PreCheck” program aimed at strengthening domestic drug manufacturing capabilities. This initiative...
Apellis Pharmaceuticals and Sobi have received a significant boost in their efforts to treat rare kidney diseases, as their drug Empaveli has been granted an expanded...
