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BioWorld - Sunday, May 3, 2026
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Financings

June 24, 2019

Product clinical data for June 20, 2019

June 21, 2019

Product regulatory actions for June 20, 2019

June 21, 2019

BioWorld MedTech's Diagnostics Extra

June 21, 2019

No withdrawals, but paclitaxel will drive longer device studies

June 21, 2019
By Mark McCarty
The second day of the advisory hearing on paclitaxel devices for the lower limbs included additional pushback against analyses by the FDA and a medical journal article. However, the panel struggled to isolate a dose-response metric that would have lent credibility to the argument that mortality is higher on these devices. Consequently, the panel recommended longer follow-up in future studies of new devices, and sponsors of existing approvals will have to ratchet up their follow-up efforts.
Read More

Imagining is the easy part in making HHS more innovation friendly

June 21, 2019
By Mari Serebrov

Startup Qualisure says its thyroid cancer diagnostic tool will curb overtreatment

June 21, 2019
By David Godkin

Gel-e gets breakthrough nod for internal bleeding solution

June 21, 2019
By Meg Bryant

Amag: All hands Andexxa to prep for Vyleesi launch as reverser nears key test

June 21, 2019
By Randy Osborne

Financings

June 21, 2019
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