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Senhwa Biosciences receives ODD for Silmitasertib from FDA to treat biliary tract cancer pharmaceutical-business-review
January 21, 2022
Senhwa Biosciences has announced the receipt of Orphan Drug Designation (ODD) from the US Food and Drug Administration...
Senhwa Biosciences Receives US FDA 'Study May Proceed' Letter to Treat BRCA2+ or PALB2+ Solid Tumors With CX-5461 prnasia
December 24, 2020
Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has received a "Study May Proceed" letter from the US Food and Drug ...
Senhwa Enrolls First Patient in Silmitasertib Trial for COVID-19 americanpharmaceuticalreview
December 04, 2020
Senhwa Biosciences announced the first patient was enrolled into a Phase II investigator-initiated trial (IIT) of its anti-SARS-CoV-2 investigational drug, Silmitasertib, as a treatment for coronavirus disease (COVID-19) at the ...
CARE Receives May Proceed Letter from FDA for COVID-19 Trial americanpharmaceuticalreview
November 17, 2020
Senhwa Biosciences announced its clinical partner, Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II ...
Senhwa Announces IND Submissions for Silmitasertib for COVID-19 americanpharmaceuticalreview
November 12, 2020
Senhwa Biosciences has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to evaluate its investigational drug Silmitasertib for the treatment of severe Coronavirus Disease 2019 (COVID-19).
Senhwa Announces Multiple IND application submissions to U.S. FDA for Silmitasertib as a Potential Treatment for COVID-19 prnasia
November 04, 2020
Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has submitted an Investigational New Drug (IND) application with the ...
Senhwa Biosciences's Silmitasertib Receives Rare Pediatric Disease Designation from U.S. FDA for Treatment of Recurrent Sonic Hedgehog Medulloblastoma prnasia
July 07, 2020
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on Next Generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Rare