Introduction In an age where novel biotechnology products are being developed on a much larger and more rapid scale at significantly higher costs and risks than ever before, it is important that this urgency is maintained through to patient access. Owing to the broad reach and the mass… Read More
The US Food & Drug Administration (FDA) has granted approval for Yuviwel (navepegritide) under its Accelerated Approval Program. Navepegritide is the only once-weekly treatment indicated to increase linear growth in children one years of age and older with achondroplasia with open epiphyses and the only one to… Read More
Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumours. Enhertu has been granted accelerated approval to treat patients who have received prior systemic treatment and… Read More
The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). The drug is approved in patients who have received at least four prior lines of therapy, including a… Read More
A potential new treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) has been validated for scientific evaluation under an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). Pharming’s investigational drug leniolisib, a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, will be evaluated as a… Read More
