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The approval for Gamifant is for paediatric, both new born and older, and adult HLH patients whose condition is refractory, recurrent or progressive or are intolerant to conventional

In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo. With the QDIP designation, intended for antibacterial drugs that treat serious

The companies reported that the trial assessing avelumab alone or in combination with PLD has not achieved the pre-specified primary endpoints of OS or PFS compared with PLD

In the trail, the clinical-stage biotechnology company will evaluate uproleselan in combination with MEC (mitoxantrone, etoposide and ara-C) or in combination with FAI (fludarabine, ara-C and idarubicin). Both

The submission is supported by a paediatric open-label study conducted in children aged six to 11 years that investigated pharmacokinetics, pharmacodynamics and long-term safety. Mepolizumab, a humanised anti-IL5

Promacta, which is marketed as Revolade in most countries outside the US, is an oral thrombopoietin receptor agonist (TPO-RA) that is already approved for SAA for patients who

The company has reported the final OS results for the phase III Mystic trial, which is a study of Imfinzi monotherapy and the combination of Imfinzi and anti-CTLA4

Nexus Pharmaceuticals chief commercial officer Omair Ahmed said: “The approval of generic Arsenic Trioxide injection continues to show Nexus’s commitment in providing access to affordable critical-need generic injectables.

This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Bristol-Myers Squibb melanoma and genitourinary