Unicycive granted FDA review for resubmitted marketing application for kidney disease drug

Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its ...
Morningstar

Ascelia Pharma Announces FDA Acceptance of Orviglance New Drug Application for Review

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...
Precision Medicine Online

Stoke Eyes 2027 New Drug Application for Dravet ASO After Fast Phase III Enrollment

The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...
Pharmabiz

Avacta Therapeutics receives US FDA clearance of investigational new drug application for FAP-Exd (AVA6103)

Avacta Therapeutics, a clinical stage biopharmaceutical company developing pre|CISION, a tumour-activated oncology delivery platform, has announced the US Food and Drug Administration (FDA) clearance ...