The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday. Last year, the FDA declined to approve the experimental therapy, citing concerns linked to manufacturing controls of the drug and device combination. The FDA, however, did not express any concerns about the clinical data submitted at that time and did not seek fresh pre-clinical or late-stage trials in its so-called complete response letter.
USA Today Four of Michigan's 2024 kickoff times are now known. Michigan's Week 2 contest against Texas was announced during the annual Spring Game on April 20, but three more game times have been announced this week.
The tech giant is holding its annual developer conference, Google I/O, in California.