News round-up for 5-9 August by DDW Senior Digital Content Editor Diana Spencer.

The news highlights this week all centre around significant US Food and Drug Administration (FDA) regulatory decisions, including new approvals for drugs for solid tumours, hepatitis B and glioma.

The top stories:

Retinoblastoma therapy gets FDA rare paediatric drug designation

Theriva Biologics’ VCN-01 for retinoblastoma has been granted rare paediatric drug designation (RPDD) by the US Food and Drug Administration (FDA).

First engineered cell therapy for a solid tumour gets US approval

Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) has become the first engineered cell therapy for a solid tumour cancer approved in the US.

Recombinant polyclonal drug trial for HBV gets FDA green light

The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.

FDA approves oral therapy for Grade 2 IDH-mutant glioma

The US Food and Drug Administration (FDA) has approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma.

FDA urged to approve MDMA-assisted therapy for PTSD

Two veteran advocacy organisations, Reason for Hope and the Veteran Mental Health Leadership Coalition, have issued a joint statement urging the FDA to approve MDMA-assisted therapy for post-traumatic stress disorder (PTSD).