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).
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).
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.
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 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 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.
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.
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.
Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients.
The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.