Visioncare's recent success in getting an FDA advisory panel to change a recommendation is a rare and noteworthy achievement. But the agency could prove to be an even more formidable barrier - and a potential catalyst for change - for the device sector going forward.
By Tom Salemi
VisionCare Ophthalmic Technologies Inc. didn't exactly crawl out of a crypt. But in the eyes of some, the Irvine,...
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.
