June 22 (Reuters) - Regenxbio (RGNX.O), opens new tab said on Monday the U.S. FDA has indicated that existing data for its rare-disease gene therapy could support an accelerated approval application, ...

In another sign that the FDA is easing its stance toward rare disease drug candidates under new leadership, the agency will reconsider Regenxbio’s gene therapy for an ultra-rare childhood disease, a ...

This content has been created by the Finextra editorial team with inputs from subject matter experts at the funding sponsor. At the Temenos Community Forum, Patrice Amann, Regional Industry Leader, ...

FDA says three-year trial data could support accelerated approval filing Agency drops demand for new sham-surgery trial Shares surge over 75% June 17 (Reuters) - UniQure (UQ1.F), opens new tab, said ...

The FDA has pulled a U-turn on uniQure’s Huntington’s disease gene therapy, giving the biotech the OK to file for accelerated approval after previously demanding data from another trial. After ...

Washington — The House rejected a war powers resolution on Thursday to constrain President Trump in Lebanon after Democratic leaders came out against it. The resolution, introduced by Democratic Rep.

This is read by an automated voice. Please report any issues or inconsistencies here. The House narrowly approved a war powers resolution to halt U.S. military action against Iran, a rare bipartisan ...

WASHINGTON (AP) — The House approved a war powers resolution that would halt the U.S. military action against Iran, defying the president as a handful of Republicans joined with Democrats to end the ...

North Korean military displays often resemble theatrical performances more than conventional combat training. From soldiers smashing bricks with their faces to extreme endurance demonstrations staged ...

Find out which new bills have been rejected by Gov. Jared Polis. His vetoes include a bill supported by Evergreen families after the shooting at their school. Then, a company in Denver is getting ...

WASHINGTON— The U.S. Army’s traditional acquisition system was not built for the speed, complexity or unpredictability of modern conflict. Threats evolve faster than requirements can be validated, ...

From Left to Right: 1. Prof. Paulo De Souza, Deputy Vice Chancellor, ECU 2. Prof. Clare Pollock, Vice Chancellor ECU 3. Rhodri Biggs, Western Australian State Government 4. Caitlin Collins MLA, ...