Hundreds of biopharma leaders say Dr Richard Pazdur has the necessary qualities to lead the FDA amid a crisis of confidence.

OTXL’s COO, Beth White, notes that the CGT marketplace could revitalise programmes that would otherwise have been indefinitely put on ice.

REGENXBIO will file for accelerated approval of the gene therapy to the FDA. Credit: Sheldon Cooper/SOPA Images/LightRocket via REGENXBIO is set to apply for US accelerated approval of its Duchenne ...

As rheumatologists prepare for EULAR 2026, Clinical Trials Arena takes a look at the most promising drugs in late-stage development for PsA.

Massive Bio has signed a strategic partnership with Just Worldwide to connect more cancer patients to clinical studies.

Biogen and Ionis' anti-tau therapy demonstrated the strongest efficacy signal at the low 60mg Q6M dose in Alzheimer's disease.

Faced with growing dominance from China, governments are transforming clinical trial frameworks to boost R&D activity.

This new high dose Wegovy data could help support Novo Nordisk in its bid to claw back market share taken by Eli Lilly in the obesity space.

QuartzBio has secured a strategic investment and majority ownership from Eir Partners to expedite its clinical trial intelligence platform.

This FDA framework comes as significant knowledge gaps remain around the efficacy and safety of drugs in pregnancy and lactation.

Dr Robert Sikorski shares his experience working with the FDA, saying its technical staff remain knowledgeable and dedicated despite recent changes.

Fractyl Health’s trial to evaluate a glucagon-like peptide-1 (GLP-1) gene therapy has been approved by European authorities. The open-label, first-in-human, Phase I/II study will investigate RJVA-001 ...