Regulatory
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
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
PRESS RELEASES