Morningstar

Kelun-Biotech's New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive ...

CHENGDU, China, Sept. 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged ...
FierceBiotech

UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again

An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been delayed—again—this time, with no new decision date given. The biotech’s candidate ...
Morningstar

VivaVision Biotech Receives Positive Written Feedback from FDA - VVN461HD New Drug Application (NDA) Requires Only a "Single Phase III" Pivotal Clinical Study in the U.S. for ...

WENZHOU, China, Jan. 6, 2026 /PRNewswire/ -- Recently, VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, ...