Food and Drug Administration (FDA)
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NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH
NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met the primary and all key secondary endpoints, and an interim analysis from an ongoing open-label extension study
Adamis Pharmaceuticals Corporation today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.
SK Life Science, Inc. Receives US FDA Approval for cenobamate tablets for the Treatment of Partial-Onset Seizures in Adults with Epilepsy
Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA
ZimetaTM should not be used more frequently than every 12 hours. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals.
First and only FDA-approved sickle hemoglobin polymerization inhibitor, a new class of therapy
As we begin the final month of 2019, the U.S. Food and Drug Administration has several PDUFA dates to approve drug applications.
Ted W. Love, president and chief executive officer of GBT, called the approval of Oxbryta a major milestone for the company and for patients with sickle cell disease.
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