Policy & Regulation
SeaStar Medical earns FDA Breakthrough Device Designation for Selective Cytopheretic Device in cardiorenal syndrome
29 September 2023 - Medical device company SeaStar Medical Holding Corporation (Nasdaq:ICU) announced on Friday that it has secured Breakthrough Device Designation from the US Food and Drug Administra...
HUTCHMED's partner Takeda submits New Drug Application for fruquintinib in Japanese market
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HitGen Inc. enters collaboration with The Structural Genomics Consortium
29 September 2023 - HitGen Inc. ('HitGen', SSE: 688222.SH), a China-based drug discovery research company, announced on Thursday that it has entered into a collaboration with The Structural ...
ImmunoGenesis doses first subject in Phase 1a/1b IMGS-001 clinical trial
29 September 2023 - ImmunoGenesis, a US-based clinical-stage biotechnology company developing science-driven immunotherapies, announced on Thursday that it has dosed its first subject in the company&#...
Mabwell doses first subject in phase Ib/II Nectin-4 trial targeting ADC in combination with PD-1 inhibitor
29 September 2023 - Mabwell (688062.SH), a China-based biopharmaceutical company, announced on Thursday that it has dosed its first subject in a phase Ib/II trial of its novel Nectin-4 targeting ADC (...
Ascletis Pharma reveals positive interim data from Phase IIb expansion cohort of ASC22 for functional cure of chronic hepatitis B
29 September 2023 - Ascletis Pharma Inc. (HKEX: 1672), a China-based R&D driven biotech company, announced on Thursday its positive interim data from the Phase IIb expansion cohort of subcutaneous...