Parkinson’s Phase II Clinical Trial Authorized by FDA
The U.S. Food and Drug Administration (FDA) has authorized the Hope Biosciences Stem Cell Research Foundation (HBSCRF) to conduct Phase II clinical trial for simultaneous allogeneic adipose-derived mesenchymal stem cells administered intravenously to treat Parkinson's...
Roche COVID-19 Molecular Test Granted EUA for PCR Testing
The U.S. Food and Drug Administration (FDA) has granted Roche Emergency Use Authorization (EUA) for its PCR cobas® SARS-CoV-2 Nucleic acid test. The EUA was granted for use on the cobas® Liat® System, and is the first RT-PCR (reverse transcriptase polymerase chain...
FDA Grants Breakthrough Therapy Designation to Novartis’ Prostate Cancer Drug Therapy
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis' prostate cancer drug therapy that is currently in Phase III development. The experimental treatment, called Lu-PSMA-617, has illustrated substantial improvements over...
“Significant Milestones” Reached on Various Regulatory Guidelines Reports ICH
The International Council for Harmonisation (ICH) has reported that "significant milestones" have been reached over the past year. From the adoption of guidances regarding carcinogenicity testing, residual solvent testing, and specifications for electronic Common...
EU Adds Another Blood Condition Side Effect to AstraZeneca’s COVID-19 Vaccine
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca's COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and body...
FDA Grants Pre-Approval for IND for Potential HIV Cure
The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences' Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an...
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