Regulation

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.

EMA grants PRIME designation to Rocket’s AAV-based gene therapy

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Rocket Pharmaceuticals’ adeno-associated virus (AAV)-based gene therapy, RP-A501, for the treatment of Danon Disease, a rare X-linked inherited disorder.

FDA committee backs Pfizer’s RSV vaccine candidate for infants

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of Pfizer’s unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate, RSVpreF or PF-06928316.