When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new ...

Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning ...

The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause ...

Medicud Srl received over €1.3 million (US$1.4 million) in seed funding to support clinical trials and secure regulatory approval of Dryum, its incisional negative pressure wound therapy system.

Hanmi Holdings Co. Ltd. has reported novel skeletal derivatives acting as HER2 mutant inhibitors and thus reported to be useful or the treatment of cancer.

Work at Laekna Therapeutics Shanghai Co. Ltd. has led to the identification of new bicyclic heteroaromatic compounds acting as Myt1 kinase (PKMYT1) inhibitors potentially useful for the treatment of ...

Ignite Biomedical Inc. and Liquid Biosciences have announced the discovery of biomarkers to diagnose substance use disorder (SUD). The set of biomarkers includes some that have not previously been ...

Sepsis-induced coagulopathy (SIC) is a complication of sepsis tied to high mortality in patients. Anticoagulation using a coagulation factor IIa and Xa dual inhibitor might have the potential to ...

Some say it’s not what you say but how you say it, but the U.S. FDA’s Feb. 10, 2025, warning letter to Denver-based Exer Labs Inc., makes clear that a 510(k)-exempt device can’t be altered and ...

Evolveimmune Therapeutics Inc. has announced a translational research collaboration with Memorial Sloan Kettering Cancer Center (MSK) to investigate the expression of a new tumor target – UL binding ...

As developers continue to search for better amyotrophic lateral sclerosis (ALS) therapies, Neurosense Therapeutics Ltd. turned up some hopeful findings from its phase IIb Paradigm trial with PrimeC.

The EU’s Medical Devices Coordination Group (MDCG) issued another revision of its guidance for risk classification for in vitro diagnostics — the fourth such rewrite of a guidance that came out in ...