FierceBiotech

Stealth Bio questions its own viability as FDA directs rare disease biotech to resubmit drug application

The FDA has denied Stealth BioTherapeutics’ request to reconsider its complete response letter, leaving the fate of the biotech and its investigational treatment for an ultrarare genetic disease ...
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 ...
Seeking Alpha

Regulatory Approval Granted for Commencement of Trinity Biotech’s Offshored and Outsourced Manufacturing of its Flagship Rapid HIV Test, Facilitating Strategic and Financial ...

DUBLIN, Aug. 20, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable ...