Medtech
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
The partners will combine Miromatrix’s single-use bioengineered liver with Baxter’s PrisMax system, which is designed to provide individualized therapies to patients.
Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
Complete Genomics showcased its innovative sequencing capacity at the Biotech Showcase 2023, one of the year’s most important investor conferences.
New Movers & Shakers took over the roles of chief executive officer, chief financial officer, chief medical officer and more at companies including Scenic Biotech, Biofrontera and X4 Pharmaceuticals.
The Biotechnology Innovation Organization, Passage Bio and Palisade Bio saw leadership shakeups at the top, while Maze Therapeutics, Cerecin and more appointed new chief medical officers.
The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
If established as safe and effective in humans, this technology could prove transformative in treating many diseases, such as diabetes.
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