Regulatory
Eisai Co., Ltd. has announced that LENVIMA, the orally available kinase inhibitor discovered by Eisai, has been accepted by the National Medical Products Administration of China for an application for the additional indication of differentiated thyroid cancer.
The Institute of Cancer Research, London, welcomes the approval by NICE of the innovative targeted cancer treatment palbociclib for women with advanced breast cancer who have already received hormone therapy.
Submission follows completion of a Clinical Endpoint study
Tetra Natural Health a wholly owned subsidiary of Tetra Bio-Pharma Inc., announced that it has submitted two over-the-counter DIN applications to Health Canada.
Avadim Health, Inc. announced that it has confidentially submitted a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission relating to the proposed initial public offering of its common stock.
Tetra Bio-Pharma Inc., announced that the U.S. Food and Drug Administration has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™, for the treatment of uncontrolled pain in advanced cancer patients.
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
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