BioSpace

IO Shuts Down Following Regulatory Roadblocks

The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing ...
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

Harbour BioMed and Kelun-Biotech Announce NMPA Approval of IND Application for HBM7575/SKB575 for the Treatment of Atopic Dermatitis

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, March 9, 2026 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of ...
Seeking Alpha

Trinity Biotech Secures Major Regulatory Approval for Offshored and Outsourced Manufacturing of Its Market Leading Uni-Gold Rapid HIV Test, Further Accelerating Financial ...

DUBLIN, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable ...
Nasdaq

PDS Biotech Receives FDA Clearance For IND Application To Treat Metastatic Colorectal Cancer

(RTTNews) - PDS Biotech (PDSB), a late-stage immunotherapy company focused on cancer treatments, announced Thursday that the U.S. Food and Drug Administration or FDA has cleared its Investigational ...
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 ...
Foreign Affairs

How America Can Win the Biotech Race

In September 2024, Akeso, a little-known Chinese biopharmaceutical company, announced that clinical trials had shown that its new drug could halt the progression of a type of lung cancer for nearly a ...
BusinessMirror

MOA signed for biotech application management

The National Committee on Biosafety of the Philippines (NCBP) and the Advanced Science and Technology Institute (ASTI) held the signing of the Memorandum of Agreement (MOA) and project kickoff for the ...