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Natera submits Signatera CDx PMA to FDA for bladder cancer use
2 February 2026 - Cell-free DNA testing company Natera Inc (NASDAQ: NTRA) said on Monday that it has submitted a premarket approval application to the US Food and Drug Administration (FDA) for Signatera CDx to detect molecular residual disease (MRD) ...
Pharming receives FDA complete response letter for paediatric Joenja application
2 February 2026 - Biopharmaceutical company Pharming Group N.V. (Euronext Amsterdam:PHARM) (NASDAQ:PHAR) revealed on Monday that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for its supplemental New Drug Application...
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
2 February 2026 - Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (NYSE: AZN) reported on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Imfinzi (durvalumab)...
I Peace generates human iPS cells from NKT cells and offers them for research use
2 February 2026 - I Peace Inc, a California-based GMP cell therapy CDMO, announced on Friday that it has generated human induced pluripotent stem (iPS) cells from NKT cells and has started offering them for research use.NKT cells are immune cells kno...
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
2 February 2026 - Trace Biosciences Inc, a US-based clinical-stage biotechnology company, announced on Saturday that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for LGW16-03, the company'...