ONIVYDE® obtains U.S. FDA approval of its supplemental new drug application

PharmaEngine announces TFDA approval of PEP07 Phase I clinical trial for solid tumor cancers

PharmaEngine announces first patient dosed in Phase I trial of PEP07 for hematological cancers

PharmaEngine announces EMA's acceptance of ONIVYDE®'s Type II Variation application

PharmaEngine files post-approval change application for a new indication of ONIVYDE® to TFDA

PharmaEngine announces Phase I clinical study of PEP07 has been approved by Taiwan Food and Drug Administration (TFDA)

PharmaEngine announces Phase I clinical study of PEP07 has been approved by Australia HREC and acknowledged by Australia TGA

PEP07: A novel, brain penetrant oral Chk1 inhibitor for the treatment of AML and MCL (6th Annual DDR Inhibitors Summit 2023)

ONIVYDE® regimen (NALIRIFOX) demonstrated statistically significant improvement in overall survival in 1L PDAC (supplementary information)

Positive topline results from Phase III NAPOLI-3 trial of ONIVYDE® regimen (NALIRIFOX) as a first-line treatment for previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)