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Moving to the fast lane: New CFDA rules target accelerated drug nods

Nov. 16, 2015

HONG KONG – The CFDA released new regulations to accelerate drug approvals and enhance the integrity of clinical data. At the same time, the regulator is soliciting opinions on a fast-lane approval process for novel drugs.

BioWorld

Free access to BioWorld coronavirus articles

BioWorld

The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are...

Vaxart shares shaken despite apparently positive early data for oral COVID-19 vaccine

BioWorld

Vaxart Inc. investors who stuck by company shares Feb. 3 had to swallow a bitter pill – watching shares of the oral vaccine developer (NASDAQ:VXRT) fall 57.8% to...

Lucira Health launches $153M IPO

BioWorld MedTech

Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of...

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BioWorld briefs for Feb. 26.

Gloved hand places sample tubes in PCR system

COVID-19 test makers are adapting for variants

BioWorld MedTech

As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their...