We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
An FDA advisory committee voted to recommend approving a formulation of desmopressin for frequent nighttime urination, with some saying it should be approved in a separate indication that had not been explicitly tested in a clinical trial. Read More
Spectrum Pharmaceuticals failed to impress an FDA advisory committee, which unanimously voted against recommending approval of the company’s treatment to prevent recurrence of low-grade non-muscle invasive bladder cancer. Read More
The FDA has determined that the results of the Xarelto clinical trial were not affected by a faulty monitoring device used in the trial, and that the drug’s approval will stand. Read More
Before the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format. Read More