Stockhead on MSN1d
Level achieved: Orthocell gains FDA approval for flagship nerve repair product
Orthocell receives US FDA 510(k) approval for Remplir, its flagship nerve repair product and can now start commercial ...
Medical Design & Outsourcing2d
Former CDRH Director Jeff Shuren on what FDA cuts might mean for device developers
"It would not be surprising if we saw longer review times, at least in the near term," Shuren said about the FDA layoffs.
Endovascular Today2d
FDA Approves New Large-Diameter Tapered Designs of Gore TAG Conformable Thoracic Stent Graft
Gore & Associates recently announced an expansion of the Gore TAG conformable thoracic stent graft with Active Control system ...
FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
Fierce Pharma3d
FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure
Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research. | Amid a dramatic reshaping of the federal ...
Fierce Pharma3d
Cellares' cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s ...
US FDA insider Steele replaces Marks as top vaccine official, for now
The U.S. Food and Drug Administration said on Tuesday it had named Scott Steele as acting director of its Center for ...