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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
Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More
The UK’s price watchdog is not recommending reimbursement for Merck’s Keytruda for the treatment of advanced or metastatic lung cancer in patients who have had at least one previous chemotherapy regimen. Read More