Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance.

In what represents just the company’s fourth PCT filing, San Jose, Calif.-based Squirrel Corp. seeks protection for systems for electroporation or pulsed field ablation (PFA) treatment of soft tissue tumors.

Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.

Molecular You Corp. said it has achieved a significant milestone in the early detection of pancreatic cancer. A case report, published in the journal OMICS, described the effectiveness of the company’s proteomic and metabolomic analysis – known as longitudinal multiomics monitoring (LMOM) – in identifying pancreatic cancer in a symptom-free 60-year-old female patient. A biopsy on lesions discovered because of the company’s diagnostic tests confirmed stage 1 pancreatic cancer.

Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year.

After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system.  

Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.

Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.