Following up on their NDA resubmission, Fennec Pharmaceuticals has been granted U.S. Food and Drug Administration (FDA) approval for its unique formulation of sodium thiosulfate called PEDMARK™. PEDMARK™ is meant to prevent ototoxicity in patients between one month...
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...
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...
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...
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...
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...
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