Food And Drug Administration

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Genprex bags FDA orphan drug designation for lung cancer therapy

By Isabel Cameron

Genprex has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).

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Finch halts biotherapeutic trial and axes 95 per cent of its staff

By Liza Laws

Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...

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CPHI NORTH AMERICA 2022

US pharma hubs: The rising stars to watch

By Rachel Arthur

CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.

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Biogen releases long-term Aduhelm data

By Rachel Arthur

Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimer’s disease pathologies.