Regulation

European Commission grants full MA to Novavax’s Covid-19 vaccine

The European Commission has granted full Marketing Authorization (MA) to Novavax’s Nuvaxovid (NVX-CoV2373) vaccine for Covid-19.

NMPA grants approval to Toray’s antipruritus medication

China’s National Medical Products Administration (NMPA) has granted approval to Toray Industries’ REMITCH nalfurafine hydrochloride orally disintegrating tablets to treat pruritus.

Taiho’s LYTGOBI tablets receive European Commission marketing authorisation

Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for LYTGOBI (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA).

FDA grants IND clearance for Phase I/IIa trial of Skyline’s SKG0106

The US Food and Drug Administration (FDA) has granted clearance for Skyline Therapeutics’ investigational new drug (IND) application for Phase I/IIa clinical trial of gene therapy SKG0106 to treat neovascular age-related macular degeneration (nAMD).

Regeneron receives FDA response letter for aflibercept’s BLA

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

FDA accepts BLA for Pfizer’s haemophilia B gene therapy

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.

GSK’s daprodustat obtains positive opinion from EMA CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending authorisation of GlaxoSmithKline’s (GSK) daprodustat for symptomatic anaemia linked to chronic kidney disease (CKD).

F2G receives Complete Response Letter for olorofim NDA

F2G has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for olorofim to treat invasive fungal infections.

Eupraxia’s EP-104IAR secures US FDA Fast Track status

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients.