Acrotech Biopharma LLC

The US Food and Drug Administration will consider study enrollment, accrual rates and clinical site activations, among other factors, in determining whether a confirmatory trial is sufficiently underw

The US first-approver advantage over the European Union remains stark, with eight of ten novel agents first cleared by the US Food and Drug Administration, according to a Pink Sheet analysis of rece

The definition of accessibility may influence whether the US Food and Drug Administration would consider efficacy concessions on a CAR-T treatment if the product were more easily available to patients

Dizal (Jiangsu) Pharmaceutical Co., Ltd. has grabbed the world’s first approval, in China, for a Janus kinase 1 (JAK1) inhibitor for the treatment of relapsed or refractory (r/r) peripheral T-cell ly