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 ...

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 ...

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 ...

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

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

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 ...

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.

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.

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).

Trethera Corp. has been awarded a $3 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH) to support evaluation of Trethera’s lead candidate, TRE-515, ...

Generative AI drug discovery company Vantai Inc. could bring in more than $1 billion in a new collaboration with Halda Therapeutics Inc. Vantai already has collaborations with other companies, ...

A new method for accelerating the maturation of neuronal cell models and brain organoids is poised to make it possible to track the etiology of neurodegenerative diseases that develop over decades.