A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical ...

In Ionis Pharmaceuticals Inc.’s second U.S. FDA approval in under a year, the agency approved Dawnzera (donidalorsen) as a prophylactic therapy in the rare and genetic disease hereditary angioedema ...

Deficiencies in interferon-stimulated gene 15 (ISG15), a protein that normally regulates the immune response, causes mild but persistent inflammation. However, its absence also provides an unexpected ...

Celldex Therapeutics Inc. will not advance barzolvolimab (CDX-0159, barzo) in eosinophilic esophagitis (EoE) after taking a ...

Cohesys Inc. conducted the first test of its resorbable Bonetape in humans as part of an investigational trial for craniofacial fractures. The tape could eliminate the use of drills and screws in many ...

Researchers at the Massachusetts Institute of Technology have developed a generative AI model that was able to generate novel antibiotic structures from either chemical fragments or de novo, starting ...

Receptor-interacting protein kinase 1 (RIPK1) plays a pivotal role in ischemic stroke pathology by mediating necroptosis and promoting neuroinflammation, both of which contribute to secondary brain ...

Quoted technology commercialization company Puretech Health plc is scouting for third parties to fund phase III development ...

Stimvia s.r.o.’s Uris system, which delivers peroneal electrical transcutaneous neuromodulation, successfully treated the symptoms of Parkinson’s disease. The non-invasive device, originally developed ...

The U.S. FDA released another series of regulations for de novo devices, but the attendant regulation is not always available for these de novo devices.

With a few tweaks to the protocol, Rocket Pharmaceuticals Inc.’s phase II trial testing RP-A501 in Danon disease is expected to resume following the lifting of the clinical hold, issued by the U.S.

Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million).