Approvals

TGA grants provisional approval to Hansa’s Idefirix as desensitisation treatment

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval to Hansa Biopharma’s Idefirix (imlifidase) as desensitisation treatment for highly sensitised patients before kidney transplantation either from living or deceased donors.

FDA approves label update of Novartis’ Leqvio to treat high LDL-C

The US Food and Drug Administration (FDA) has approved a label update of Novartis’ Leqvio (inclisiran) to allow earlier use in patients suffering with high LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy.

FDA clears 280Bio’s IND to start Phase I trial of YL-17231

The US Food and Drug Administration (FDA) has granted clearance to 280Bio’s investigational new drug (IND) application, thereby enabling initiation of a Phase I study of YL-17231 to treat patients with advanced cancer with RAS mutations.

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.

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.

Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

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.

US FDA declines to approve Ascendis Pharma’s TransCon PTH NDA

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.