News

Tenapanor is Ardelyx's investigational, minimally systemic, small-molecule NHE3 inhibitor. The T3MPO-1 trial achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. The primary endpoint,

"The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this

The company’s MedImmune unit carried out the Pacific trial, met one of its primary endpoint of progression-free survival (PFS) in patients with locally-advanced, stage three non-small cell lung cancer (NSCLC).

The grant, entitled "Cell2Sell – commercial scale next generation platform for allogeneic stem cell production", has been awarded under Innovate UK's Cell & Gene Therapies Industrial Manufacture grant

Niraparib is currently an investigational agent in Europe and as such has not been granted approval by the European Commission. The niraparib marketing authorisation application is under review

Hikma has secured a complete response letter (CRL) from the FDA on the abbreviated new drug application (ANDA). According to Vectura, the FDA has categorised the CRL as

The safety profile observed in IMvigor211 was consistent with what has been previously observed for Tecentriq.  “While these results are not what we had expected, we believe that

Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon

Post merger, INC Research shareholders are likely to hold nearly 53% stake in the combimned company. inVentiv shareholders will hold the remainder stake. The merger is expected to