Regulatory

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FDA Grants Accelerated Approval to Bristol Myers Squibb’s Augtyro for the Treatment of NTRK-Positive Locally Advanced or Metastatic Solid Tumors
FDA Grants Accelerated Approval to Bristol Myers Squibb’s Augtyro for the Treatment of NTRK-Positive Locally Advanced or Metastatic Solid Tumors

June 14th 2024

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

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FDA Issues Complete Response Letter to sBLA for Four-Dose Heplisav-B Regimen in Adults on Hemodialysis

May 14th 2024

Faint Hopes of Dispelling the Fog Around Cross-Border Trials in Europe
Faint Hopes of Dispelling the Fog Around Cross-Border Trials in Europe

May 14th 2024

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Beyond the Black Box: Tailoring AI Regulation in Healthcare

April 30th 2024

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