Regulation

FDA grants orphan drug status to Ractigen’s RAG-18 for DMD and BMD

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).

GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GSK's investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227).

FDA grants Fast Track Designation to Arthrosi Therapeutics’s AR882 for gout treatment

Arthrosi Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug AR882, aimed at treating gout patients with clinically visible tophi.

EMA validates Type II Variation application for ENHERTU for breast cancer treatment

Daiichi Sankyo has announced that the European Medicines Agency (EMA) validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have previously undergone a minimum of one endocrine therapy in the metastatic setting.

FDA grants priority review for Bavarian Nordic’s chikungunya vaccine BLA

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.

Sandoz’s Enzeevu secures FDA approval for nAMD treatment

The US Food and Drug Administration (FDA) has granted approval for Sandoz's Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar aimed at treating neovascular age-related macular degeneration (nAMD).

US FDA approves Purdue Pharma’s Zurnai auto-injector

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.

FDA accepts Exelixis’ cabozantinib sNDA for neuroendocrine tumours

The US Food and Drug Administration (FDA) has accepted Exelixis’ supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX) to treat two potential indications in advanced neuroendocrine tumours (NETs).

Health Canada grants approval for Celltrion’s Steqeyma for multiple conditions

Health Canada has granted approval for Celltrion Healthcare Canada’s Steqeyma (ustekinumab injection) and Steqeyma IV (ustekinumab for injection, solution for intravenous infusion) for treating various chronic inflammatory conditions.