Takara Bio Submits IND Application to FDA for HF10 Anti-Cancer TherapyOta, Jun
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. ...
Indevus Submits Data To FDA With New Dosing Regimen For Hypogonadism CandidateJoseph Haas
Telix Pharmaceuticals has announced that it has submitted a phase 3 investigational new drug (IND) application to the US Food and Drug Administration (US FDA) for TLX250-CDx as part of the international phase 3 ZIRCON study. The ZIRCON study is expected to commence enrolling US patients in ...
not limited to the impact of Covid-19; the Company's ability to obtain adequate financing in the future; the impact of promulgation and implementation of regulations by the World Health Organization, the ...
“We believe our preclinical work on SPC-15, supported by published preclinical data, provides a strong foundation for our development strategies and initial clinical trial design. We anticipate that our pre-IND submission will lead to valuable guidance from the FDA as we prepare for the first-...
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 rec...
Supports investigational and marketing application submissions (IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more) Compile eCTD submissions for various health authorities including: US FDA European Medicines Agency (EMA) Health Canada Swissmedic Australia’s Therapeutic Goods Administration (TG...
(Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it submitted an updated Investigational New Drug (IND) application for BT-600 to the U.S. Food and Drug Administration (FDA) as planned. The update includes additional cl...
(IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 recep...