Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.

A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.

Chimera Bioengineering Inc. has been selected as the winner of the Asian Fund for Cancer Research's (AFCR) 2021 BRACE Award Venture Competition, contributing $500,000 as part of a recent $7.5 million capital infusion and bringing to $26 million the company’s total amount raised to date.

China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).

Engimmune Therapeutics AG has raised CHF15.5 million (US$16.7 million) in a seed round, as it prepares to address efficacy and safety shortcomings that currently constrain T-cell receptor and soluble TCR cancer therapies. The Basel, Switzerland-based company’s technology brings together genome editing, functional screening, deep mutational sequencing and machine learning, to engineer synthetic T-cell receptors that are highly specific to a chosen tumor antigen, increasing affinity and safety and avoiding off-target effects.