Speciality biopharmaceutical company Adamis Pharmaceuticals has submitted an Investigational New Drug (IND) to the US Food and Drug Administration (FDA) for the use of Tempol to treat Covid-19. The submission for the investigational use of Tempol comes after a Pre-IND meeting with the FDA, where...
Takara Bio Submits IND Application to FDA for HF10 Anti-Cancer TherapyOta, Jun
Arch Biopartners Inc. recently announced it has submitted an Investigational New Drug (IND) Application to the US FDA for its lead drug Metablok (LSALT peptide) to conduct a Phase 2 trial to prevent acute organ inflammation and injury experienced by patients with COVID-19. The submission of...
Celltrion said it submitted an investigational new drug (IND) application to the U.S. FDA for the phase 3 clinical trial of CT-P51, its Keytruda (ingredient: pembrolizumab) biosimilar. Celltrion submitted its IND application for a phase 3 clinical trial into CT-P51, a Keytruda biosimilar, to...
Indevus Submits Data To FDA With New Dosing Regimen For Hypogonadism CandidateJoseph Haas
Mesoblast Limited announced that it has submitted to the U.S. Food and Drug Administration substantial new information on clinical and potency assay items identified in the Complete Response Letter received from FDA in September 2020 to the Biologics...
Elucida Oncology announced today that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of ELU-001 MONMOUTH JUNCTION, N.J., July 19, 2021...
(FSE/XETRA: PSH), a leading regenerative medicine company focused on developing its Cell Pouch bio-hybrid organ as a functional cure for type 1 diabetes, today announced the submission of an Investigational New Drug (...
ARCA biopharma has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. P...
for CTIM-76 and the indications to be part of such trials, (ii) our expectation regarding the trial design of any CTIM-76 trial, (iii) our belief regarding the quality of the data included in our IND for CTIM-76, (iv) our expectation to receive IND clearance from the FDA for C...