FDA grants orphan drug status for RedHill’s opaganib for neuroblastoma
The US Food and Drug Administration (FDA) has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a childhood cancer.
The US Food and Drug Administration (FDA) has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a childhood cancer.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Ractigen Therapeutics' RAG-18, a small activating RNA (saRNA) product candidate for the treatment of Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD).
Aarvik Therapeutics has announced that its collaboration partner ArriVent BioPharma opted to exclusively license their joint programme.
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Bavarian Nordic's chikungunya virus vaccine candidate, CHIKV VLP, granting it priority review status.
The US Food and Drug Administration (FDA) has approved Purdue Pharma’s new drug application for Zurnai, the first nalmefene hydrochloride auto-injector, designed for the emergency treatment of opioid overdose.
Santen Pharmaceutical has entered into a licensing agreement with Cloudbreak Pharma to develop, manufacture, and commercialise CBT-001, a topical pterygium treatment, for certain territories.
Genmab has assumed the complete ownership of the acasunlimab development programme, including its continued development and potential commercialisation, contingent on approval.
Biotechnology company Jade Biosciences has announced the successful closure of an $80m financing round aimed at developing transformative therapies for autoimmune diseases.
Pinetree Therapeutics has secured $17m in a Series A funding round to advance its new multispecific targeted protein degraders (TPD) development programmes.
Belgium-based Confo Therapeutics has secured €60m ($65m) in a Series B financing round to propel its pipeline of G protein-coupled receptor (GPCR)-modulating therapies into clinical development.